- Bayer will showcase latest data for growth driver NUBEQA®
(darolutamide) and targeted radionuclide therapy XOFIGO® (radium Ra
223 dichloride)
- Bayer will also present a late-breaking abstract on the Phase
I/II study of BAY 2927088 in patients with HER2-mutant non-small
cell lung cancer (NSCLC), and data from VITRAKVI® in patients with
tropomyosin receptor kinase (TRK) fusion lung cancer
Abstracts: 5022, 5083, TPS5122, TPS5127, e17040, LBA8598,
8570, 6095, 3105
Bayer will present new data across its oncology portfolio at the
upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting, taking place in Chicago, from May 31 – June 4, 2024. The
breadth of new data in different tumor types underscores Bayer’s
ambition to deliver innovative and effective oncological therapies
in areas with the highest unmet medical needs.
Prostate cancer is a key focus for Bayer Oncology, with data to
be presented on NUBEQA® (darolutamide) and XOFIGO® (radium Ra 223
dichloride) across multiple stages of the disease. NUBEQA data will
include a post hoc analysis from the Phase III ARASENS trial,
evaluating post-progression survival with NUBEQA and
androgen-deprivation therapy (ADT) plus docetaxel in patients with
metastatic hormone-sensitive prostate cancer (mHSPC), which will
further support the established efficacy profile of NUBEQA.
Additionally a follow-up analysis from the Phase III ARAMIS trial,
evaluating the association between prostate-specific antigen (PSA)
level and risk of radiological progression with NUBEQA and ADT in
patients with non-metastatic castration-resistant prostate cancer
(nmCRPC) will also be presented.
An overview of the ongoing investigational Phase III ARASTEP
trial in hormone sensitive prostate cancer patients with high-risk
biochemical recurrence will also be presented. Additionally, new
data from the ongoing Bayer sponsored ALADDIN study, conducted by
the Association Pour La Recherche des Thérapeutiques Innovantes en
Cancérologie, investigating the impact of NUBEQA plus ADT and
radiation therapy on failure-free survival in patients with newly
diagnosed prostate cancer and pelvic lymph nodes metastases will be
presented.
NUBEQA is currently indicated in the U.S. in combination with
docetaxel for the treatment of adult patients with mHSPC and for
the treatment of adult patients with non-metastatic
castration-resistant prostate cancer (nmCRPC).
In the field of targeted radionuclide therapies, Bayer will
present data from the Phase III REASSURE study, evaluating patient
profiles and treatment outcomes in patients with metastatic
castration resistant prostate cancer (mCRPC) with XOFIGO in the
real-world setting, will be shared. XOFIGO is indicated for the
treatment of patients with mCRPC, symptomatic bone metastases, and
no known visceral metastatic disease.
Bayer will present a late-breaking abstract on BAY 2927088 in
patients with HER2-mutant non-small cell lung cancer (NSCLC) from
the Phase I/II SOHO-01 trial. BAY 2927088 is an oral, small
molecule tyrosine kinase inhibitor being investigated for patients
with NSCLC harboring HER2 activating mutations.
Bayer will highlight long-term efficacy and safety data from the
VICTORIA study for VITRAKVI®, including outcomes in patients with
tropomyosin receptor kinase (TRK) fusion cancer treated with
VITRAKVI in clinical trials (NCT02122913, NCT02576431,
NCT02637687). Vitrakvi is approved for the treatment of adult and
pediatric patients with solid tumors that have a NTRK gene fusion
without a known acquired resistance mutation, are metastatic or
where surgical resection is likely to result in severe morbidity,
and have no satisfactory alternative treatments or that have
progressed following treatment. Patients should be selected for
therapy based on a FDA-approved test. This indication is approved
under accelerated approval based on overall response rate (ORR) and
duration of response. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
confirmatory trials.
Details on selected abstracts from Bayer at the 2024 ASCO Annual
Meeting are listed below:
Darolutamide
- Abstract title: Association between prostate-specific
antigen (PSA) level <0.2 ng/mL and risk of radiological
progression in patients (pts) with nonmetastatic
castration-resistant prostate cancer (nmCRPC): Follow-up analysis
of ARAMIS
- Poster: 5022; June 2, 2024. 09:00 AM – 12:00 PM CDT
- Abstract title: Post-progression survival of patients with
metastatic hormone-sensitive prostate cancer (mHSPC) who received
darolutamide or placebo: Post hoc analysis of ARASENS
- Poster: 5083; June 2, 2024. 09:00 AM – 12:00 PM CDT
- Abstract title: Darolutamide plus androgen-deprivation
therapy (ADT) in patients with high-risk biochemical recurrence
(BCR) of prostate cancer: A phase 3, randomized, double-blind,
placebo-controlled study (ARASTEP) Trial in Progress
- TiP Poster: TPS5122; June 2, 2024. 09:00 AM – 12:00 PM CDT
- Abstract title: ALADDIN: Evaluation of darolutamide in
addition to androgen deprivation therapy and radiation therapy in
newly diagnosed prostate cancer with pelvic lymph nodes
metastases
- TiP Poster: TPS5127; June 2, 2024. 9:00AM CDT
Radium-223 dichloride
- Abstract title: Comparing patient profiles and treatment
outcomes with radium-223 (223Ra) in real-world settings: Academic
vs. community practice in the US—Insights from the REASSURE
study
- ePoster: e17040; Published J Clin Oncol 42, 2024, suppl 16
BAY 2927088
- Abstract title: Safety and clinical activity of BAY 2927088
from a Phase I/II trial expansion cohort in patients with
HER2-mutant non-small cell lung cancer (NSCLC)
- Late Breaking Abstract: LBA8598; June 3, 2024. 1:30PM CDT
Larotrectinib
- Abstract title: Long-term efficacy and safety of
larotrectinib in patients (pts) with TRK fusion lung cancer
- Poster: 8570; June 3, 2024. 1:30PM CDT
- Abstract title: Long-term efficacy and safety of
larotrectinib (laro) in patients (pts) with TRK fusion thyroid
carcinoma (TC)
- Poster: 6095; June 2, 2024. 9:00AM CDT
- Abstract title: Outcomes of larotrectinib compared with
real-world data from non-TRK inhibitor therapies in patients with
TRK fusion cancer: VICTORIA study
- Poster: 3105; June 1, 2024. 9:00AM CDT
About NUBEQA® (darolutamide)1
NUBEQA® (darolutamide) is an androgen receptor inhibitor (ARi)
with a distinct chemical structure that competitively inhibits
androgen binding, AR nuclear translocation, and AR-mediated
transcription.
On July 30, 2019, the FDA approved NUBEQA based on the ARAMIS
trial, a randomized, double-blind, placebo-controlled, multi-center
Phase III study, which evaluated the safety and efficacy of oral
NUBEQA in patients with non-metastatic castration-resistant
prostate cancer (nmCRPC).
Based on results from the ARASENS trial, a randomized, Phase
III, multi-center, double-blind, placebo-controlled trial, NUBEQA
plus androgen deprivation therapy (ADT) and docetaxel was approved
on August 5, 2022 for the treatment of adult patients with
metastatic hormone-sensitive prostate cancer (mHSPC).
NUBEQA is also being investigated in additional studies across
various stages of prostate cancer, including in the Phase III
ARANOTE trial evaluating NUBEQA plus ADT versus ADT alone for
mHSPC, the ARASTEP Phase III trial evaluating NUBEQA plus ADT
versus ADT alone in HSPC patients with high-risk BCR and no
evidence of metastatic disease, as well as in the Australian and
New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP) led
international Phase III co-operative group DASL-HiCaP (ANZUP1801)
trial evaluating NUBEQA as an adjuvant treatment for localized
prostate cancer with very high risk of recurrence. Information
about these trials can be found at www.clinicaltrials.gov.
Developed jointly by Bayer and Orion Corporation, a globally
operating Finnish pharmaceutical company, NUBEQA is indicated for
the treatment of adults with nmCRPC or with mHSPC in combination
with docetaxel.1 Filings in other regions are underway or
planned.
INDICATIONS
NUBEQA® (darolutamide) is an androgen receptor inhibitor
indicated for the treatment of adult patients with:
- Non-metastatic castration-resistant prostate cancer
(nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in
combination with docetaxel
IMPORTANT SAFETY INFORMATION
NUBEQA® (darolutamide) is an androgen receptor inhibitor
indicated for the treatment of adult patients with:
- Non-metastatic castration-resistant prostate cancer
(nmCRPC)
- Metastatic hormone-sensitive prostate cancer (mHSPC) in
combination with docetaxel
IMPORTANT SAFETY INFORMATION
Warnings & Precautions
Ischemic Heart Disease – In a study
of patients with nmCRPC (ARAMIS), ischemic heart disease occurred
in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo,
including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic
events led to death in 0.3% of patients receiving NUBEQA vs. 0.2%
receiving placebo. In a study of patients with mHSPC (ARASENS),
ischemic heart disease occurred in 3.2% of patients receiving
NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel,
including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic
events led to death in 0.3% of patients receiving NUBEQA with
docetaxel vs. 0% receiving placebo with docetaxel. Monitor for
signs and symptoms of ischemic heart disease. Optimize management
of cardiovascular risk factors, such as hypertension, diabetes, or
dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart
disease.
Seizure – In ARAMIS, Grade 1-2
seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2%
receiving placebo. Seizure occurred 261 and 456 days after
initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of
patients receiving NUBEQA with docetaxel, including one Grade 3
event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred
38 to 340 days after initiation of NUBEQA. It is unknown whether
antiepileptic medications will prevent seizures with NUBEQA. Advise
patients of the risk of developing a seizure while receiving NUBEQA
and of engaging in any activity where sudden loss of consciousness
could cause harm to themselves or others. Consider discontinuation
of NUBEQA in patients who develop a seizure during treatment.
Embryo-Fetal Toxicity – Safety and
efficacy of NUBEQA have not been established in females. NUBEQA can
cause fetal harm and loss of pregnancy. Advise males with female
partners of reproductive potential to use effective contraception
during treatment with NUBEQA and for 1 week after the last
dose.
Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients
receiving NUBEQA vs. 20% of patients receiving placebo. Serious
adverse reactions in ≥1% of patients who received NUBEQA included
urinary retention, pneumonia, and hematuria. Fatal adverse
reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of
patients receiving placebo. Fatal adverse reactions in patients who
received NUBEQA included death (0.4%), cardiac failure (0.3%),
cardiac arrest (0.2%), general physical health deterioration
(0.2%), and pulmonary embolism (0.2%). The most common adverse
reactions (>2% with a ≥2% increase over placebo), including
laboratory test abnormalities, were increased AST, decreased
neutrophil count, fatigue, increased bilirubin, pain in extremity
and rash. Clinically relevant adverse reactions occurring in ≥2% of
patients treated with NUBEQA included ischemic heart disease and
heart failure.
In ARASENS, serious adverse reactions occurred in 45% of
patients receiving NUBEQA with docetaxel vs. 42% of patients
receiving placebo with docetaxel. Serious adverse reactions in ≥2%
of patients who received NUBEQA with docetaxel included febrile
neutropenia (6%), decreased neutrophil count (2.8%),
musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse
reactions occurred in 4% of patients receiving NUBEQA with
docetaxel vs. 4% of patients receiving placebo with docetaxel.
Fatal adverse reactions in patients who received NUBEQA included
COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%),
and sudden death (0.3%). The most common adverse reactions (≥10%
with a ≥2% increase over placebo with docetaxel) were constipation,
rash, decreased appetite, hemorrhage, increased weight, and
hypertension. The most common laboratory test abnormalities (≥30%)
were anemia, hyperglycemia, decreased lymphocyte count, decreased
neutrophil count, increased AST, increased ALT, and hypocalcemia.
Clinically relevant adverse reactions in <10% of patients who
received NUBEQA with docetaxel included fractures, ischemic heart
disease, seizures, and drug-induced liver injury.
Drug Interactions
Effect of Other Drugs on NUBEQA –
Combined P-gp and strong or moderate CYP3A4 inducers decrease
NUBEQA exposure, which may decrease NUBEQA activity. Avoid
concomitant use.
Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA
exposure, which may increase the risk of NUBEQA adverse reactions.
Monitor more frequently and modify NUBEQA dose as needed.
Effects of NUBEQA on Other Drugs –
NUBEQA inhibits breast cancer resistance protein (BCRP)
transporter. Concomitant use increases exposure (AUC) and maximal
concentration of BCRP substrates, which may increase the risk of
BCRP substrate-related toxicities. Avoid concomitant use where
possible. If used together, monitor more frequently for adverse
reactions, and consider dose reduction of the BCRP substrate.
NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant
use may increase plasma concentrations of OATP1B1 or OATP1B3
substrates. Monitor more frequently for adverse reactions and
consider dose reduction of these substrates.
Review the Prescribing Information of drugs that are BCRP,
OATP1B1, and OATP1B3 substrates when used concomitantly with
NUBEQA.
For important risk and use information about NUBEQA, please
see the accompanying full Prescribing
Information.
About XOFIGO (radium Ra 223 dichloride) Injection2
Xofigo is indicated for the treatment of patients with
castration-resistant prostate cancer, symptomatic bone metastases
and no known visceral metastatic disease.
Important Safety Information for Xofigo® (radium Ra 223
dichloride) Injection
Warnings and Precautions:
- Bone Marrow Suppression: In the phase 3 ALSYMPCA trial,
2% of patients in the Xofigo arm experienced bone marrow failure or
ongoing pancytopenia, compared to no patients treated with placebo.
There were two deaths due to bone marrow failure. For 7 of 13
patients treated with Xofigo bone marrow failure was ongoing at the
time of death. Among the 13 patients who experienced bone marrow
failure, 54% required blood transfusions. Four percent (4%) of
patients in the Xofigo arm and 2% in the placebo arm permanently
discontinued therapy due to bone marrow suppression. In the
randomized trial, deaths related to vascular hemorrhage in
association with myelosuppression were observed in 1% of
Xofigo-treated patients compared to 0.3% of patients treated with
placebo. The incidence of infection-related deaths (2%), serious
infections (10%), and febrile neutropenia (<1%) was similar for
patients treated with Xofigo and placebo. Myelosuppression–notably
thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has
been reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow
reserve closely and provide supportive care measures when
clinically indicated. Discontinue Xofigo in patients who experience
life-threatening complications despite supportive care for bone
marrow failure
- Hematological Evaluation: Monitor blood counts at
baseline and prior to every dose of Xofigo. Prior to first
administering Xofigo, the absolute neutrophil count (ANC) should be
≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10
g/dL. Prior to subsequent administrations, the ANC should be ≥1 ×
109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if
hematologic values do not recover within 6 to 8 weeks after the
last administration despite receiving supportive care
- Concomitant Use With Chemotherapy: Safety and efficacy
of concomitant chemotherapy with Xofigo have not been established.
Outside of a clinical trial, concomitant use of Xofigo in patients
on chemotherapy is not recommended due to the potential for
additive myelosuppression. If chemotherapy, other systemic
radioisotopes, or hemibody external radiotherapy are administered
during the treatment period, Xofigo should be discontinued
- Increased Fractures and Mortality in Combination With
Abiraterone Plus Prednisone/Prednisolone: Xofigo is not
recommended for use in combination with abiraterone acetate plus
prednisone/prednisolone outside of clinical trials. At the primary
analysis of the Phase 3 ERA-223 study that evaluated concurrent
initiation of Xofigo in combination with abiraterone acetate plus
prednisone/prednisolone in 806 asymptomatic or mildly symptomatic
mCRPC patients, an increased incidence of fractures (28.6% vs
11.4%) and deaths (38.5% vs 35.5%) have been observed in patients
who received Xofigo in combination with abiraterone acetate plus
prednisone/prednisolone compared to patients who received placebo
in combination with abiraterone acetate plus
prednisone/prednisolone. Safety and efficacy with the combination
of Xofigo and agents other than gonadotropin-releasing hormone
analogues have not been established
- Embryo-Fetal Toxicity: The safety and efficacy of Xofigo
have not been established in females. Xofigo can cause fetal harm
when administered to a pregnant female. Advise pregnant females and
females of reproductive potential of the potential risk to a fetus.
Advise male patients to use condoms and their female partners of
reproductive potential to use effective contraception during and
for 6 months after completing treatment with Xofigo
Administration and Radiation Protection: Xofigo should be
received, used, and administered only by authorized persons in
designated clinical settings. The administration of Xofigo is
associated with potential risks to other persons from radiation or
contamination from spills of bodily fluids such as urine, feces, or
vomit. Therefore, radiation protection precautions must be taken in
accordance with national and local regulations
Fluid Status: Dehydration occurred in 3% of patients on Xofigo
and 1% of patients on placebo. Xofigo increases adverse reactions
such as diarrhea, nausea, and vomiting, which may result in
dehydration. Monitor patients’ oral intake and fluid status
carefully and promptly treat patients who display signs or symptoms
of dehydration or hypovolemia
Injection Site Reactions: Erythema, pain, and edema at the
injection site were reported in 1% of patients on Xofigo
Secondary Malignant Neoplasms: Xofigo contributes to a patient’s
overall long-term cumulative radiation exposure. Long-term
cumulative radiation exposure may be associated with an increased
risk of cancer and hereditary defects. Due to its mechanism of
action and neoplastic changes, including osteosarcomas, in rats
following administration of radium-223 dichloride, Xofigo may
increase the risk of osteosarcoma or other secondary malignant
neoplasms. However, the overall incidence of new malignancies in
the randomized trial was lower on the Xofigo arm compared to
placebo (<1% vs 2%; respectively), but the expected latency
period for the development of secondary malignancies exceeds the
duration of follow-up for patients on the trial
Subsequent Treatment With Cytotoxic Chemotherapy: In the
randomized clinical trial, 16% of patients in the Xofigo group and
18% of patients in the placebo group received cytotoxic
chemotherapy after completion of study treatments. Adequate safety
monitoring and laboratory testing was not performed to assess how
patients treated with Xofigo will tolerate subsequent cytotoxic
chemotherapy
Adverse Reactions: The most common adverse reactions (≥10%) in
the Xofigo arm vs the placebo arm, respectively, were nausea (36%
vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and
peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were
reported in 57% of Xofigo-treated patients and 63% of
placebo-treated patients. The most common hematologic laboratory
abnormalities in the Xofigo arm (≥10%) vs the placebo arm,
respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs
53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and
neutropenia (18% vs 5%)
Please see the full Prescribing Information for Xofigo (radium
Ra 223 dichloride).
About VITRAKVI® (larotrectinib)3
VITRAKVI is indicated for the treatment of adult and pediatric
patients with solid tumors that:
- have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion
without a known acquired resistance mutation,
- are metastatic or where surgical resection is likely to result
in severe morbidity, and
- have no satisfactory alternative treatments or that have
progressed following treatment.
Select patients for therapy based on an FDA-approved test.
This indication is approved under accelerated approval based on
overall response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
- Central Nervous System Effects: Central nervous system
(CNS) adverse reactions occurred in patients receiving VITRAKVI,
including dizziness, cognitive impairment, mood disorders, and
sleep disturbances. In patients who received VITRAKVI, all grades
CNS effects including cognitive impairment, mood disorders,
dizziness and sleep disorders were observed in 42% with Grades 3-4
in 3.9% of patients. Cognitive impairment occurred in 11% of
patients. The median time to onset of cognitive impairment was 5.6
months (range: 2 days to 41 months). Cognitive impairment occurring
in ≥ 1% of patients included memory impairment (3.6%), confusional
state (2.9%), disturbance in attention (2.9%), delirium (2.2%),
cognitive disorders (1.4%), and Grade 3 cognitive adverse reactions
occurred in 2.5% of patients. Among the 30 patients with cognitive
impairment, 7% required a dose modification and 20% required dose
interruption. Mood disorders occurred in 14% of patients. The
median time to onset of mood disorders was 3.9 months (range: 1 day
to 40.5 months). Mood disorders occurring in ≥1% of patients
included anxiety (5%), depression (3.9%), agitation (2.9%), and
irritability (2.9%). Grade 3 mood disorders occurred in 0.4% of
patients. Dizziness occurred in 27% of patients, and Grade 3
dizziness occurred in 1.1% of patients. Among the 74 patients who
experienced dizziness, 5% of patients required a dose modification
and 5% required dose interruption. Sleep disturbances occurred in
10% of patients. Sleep disturbances included insomnia (7%),
somnolence (2.5%), and sleep disorder (0.4%). There were no Grade
3-4 sleep disturbances. Among the 28 patients who experienced sleep
disturbances, 1 patient each (3.6%) required a dose modification or
dose interruption. Advise patients and caretakers of these risks
with VITRAKVI. Advise patients not to drive or operate hazardous
machinery if they are experiencing neurologic adverse reactions.
Withhold or permanently discontinue VITRAKVI based on the severity.
If withheld, modify the VITRAKVI dosage when resumed.
- Skeletal Fractures: Among 187 adult patients who
received VITRAKVI across clinical trials, fractures were reported
in 7% and among 92 pediatric patients, fractures were reported in
9% (N=279; 8%). Median time to fracture was 11.6 months (range 0.9
to 45.8 months) in patients followed per fracture. Fractures of the
femur, hip or acetabulum were reported in 4 patients (3 adult, 1
pediatric). Most fractures were associated with minimal or moderate
trauma. Some fractures were associated with radiologic
abnormalities suggestive of local tumor involvement. VITRAKVI
treatment was interrupted due to fracture in 1.4% patients.
Promptly evaluate patients with signs or symptoms of potential
fracture (e.g., pain, changes in mobility, deformity). There are no
data on the effects of VITRAKVI on healing of known fractures or
risk of future fractures.
- Hepatotoxicity: Hepatotoxicity including drug induced
liver injury (DILI) has been reported in patients taking VITRAKVI.
In patients who received VITRAKVI, increased AST of any grade
occurred in 52% of patients and increased ALT of any grade occurred
in 45%. Grade 3-4 increased AST or ALT occurred in 3.1% and 2.5% of
patients, respectively. The median time to onset of increased AST
was 2.1 months (range: 1 day to 4.3 years). The median time to
onset of increased ALT was 2.3 months (range: 1 day to 4.2 years).
Increased AST and ALT leading to dose modifications occurred in
1.4% and 2.2% of patients, respectively. Increased AST or ALT led
to permanent discontinuation in 3 (1.1%) of patients. There have
been reports in adult patients from clinical studies and
post-marketing cases of Grade ≥ 2 increases in ALT and/or AST with
increases in bilirubin ≥ 2 x ULN. Obtain liver function tests (ALT,
AST, ALP and bilirubin) before initiation of VITRAKVI and monitor
every 2 weeks during the first two months of treatment, then
monthly thereafter, or more frequently following the occurrence of
Grade 2 or greater AST or ALT elevation. Temporarily withhold,
reduce the dose, or permanently discontinue VITRAKVI based on
severity.
- Embryo-Fetal Toxicity: VITRAKVI can cause fetal harm
when administered to a pregnant woman. Larotrectinib resulted in
malformations in rats and rabbits at maternal exposures that were
approximately 11- and 0.7-times, respectively, those observed at
the clinical dose of 100 mg twice daily. Advise women of the
potential risk to a fetus. Advise females of reproductive potential
to use an effective method of contraception during treatment and
for 1 week after the last dose of VITRAKVI.
Adverse Reactions
- The most common adverse reactions (≥20%), including laboratory
abnormalities, were: increased AST (52%), increased ALT (45%),
anemia (42%), musculoskeletal pain (42%), fatigue (36%),
hypoalbuminemia (36%), neutropenia (36%), increased alkaline
phosphatase (34%), cough (32%), leukopenia (28%), constipation
(27%), diarrhea (27%), dizziness (27%), hypocalcemia (25%), nausea
(25%), vomiting (25%), pyrexia (24%), lymphopenia (22%) and
abdominal pain (21%).
Drug Interactions
- Avoid coadministration of VITRAKVI with strong CYP3A4
inhibitors (including grapefruit or grapefruit juice), strong
CYP3A4 inducers (including St. John’s wort), or sensitive CYP3A4
substrates. If coadministration of strong CYP3A4 inhibitors or
inducers cannot be avoided, modify the VITRAKVI dose as
recommended. If coadministration of sensitive CYP3A4 substrates
cannot be avoided, monitor patients for increased adverse reactions
of these drugs. For coadministration with moderate CYP3A4
inhibitors, monitor for adverse reactions more frequently and
reduce the dosage based on severity. For coadministration with
moderate CYP3A4 inducers, modify dose as recommended.
Use in Specific Populations
- Lactation: Advise women not to breastfeed during treatment with
VITRAKVI and for 1 week after the last dose.
Please see the full Prescribing Information for VITRAKVI®
(larotrectinib).
About Oncology at Bayer
Bayer is committed to delivering science for a better life by
advancing a portfolio of innovative treatments. The oncology
franchise at Bayer includes six marketed products and several other
assets in various stages of clinical development. Together, these
products reflect the company’s approach to research, which
prioritizes targets and pathways with the potential to impact the
way that cancer is treated.
About Bayer
Bayer is a global enterprise with core competencies in the life
science fields of health care and nutrition. In line with its
mission, “Health for all, Hunger for none,” the company’s products
and services are designed to help people and the planet thrive by
supporting efforts to master the major challenges presented by a
growing and aging global population. Bayer is committed to driving
sustainable development and generating a positive impact with its
businesses. At the same time, the Group aims to increase its
earning power and create value through innovation and growth. The
Bayer brand stands for trust, reliability and quality throughout
the world. In fiscal 2023, the Group employed around 100,000 people
and had sales of 47.6 billion euros. R&D expenses before
special items amounted to 5.8 billion euros. For more information,
go to www.bayer.com.
© 2024 Bayer
BAYER, the Bayer Cross, NUBEQA, XOFIGO and VITRAKVI are
registered trademarks of Bayer.
Forward-Looking Statements
This release may contain forward-looking statements based on
current assumptions and forecasts made by Bayer management. Various
known and unknown risks, uncertainties and other factors could lead
to material differences between the actual future results,
financial situation, development or performance of the company and
the estimates given here. These factors include those discussed in
Bayer’s public reports which are available on the Bayer website at
www.bayer.com. The company assumes no liability whatsoever to
update these forward-looking statements or to conform them to
future events or developments.
References
- NUBEQA® (darolutamide) tablets [Prescribing Information].
Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2024.
- XOFIGO® (radium-223 dichloride Injection [Prescribing
Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April
2024.
- VITRAKVI® (larotrectinib) [Package Insert]. Whippany, NJ: Bayer
HealthCare Pharmaceuticals, April 2024.
PP-PF-ONC-US-3156-1 5/24
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Media Contact: Carolyn Nagle, Tel + 201.419.0337 Email:
Carolyn.Nagle@bayer.com