SAN
DIEGO, Feb. 3, 2025 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that
Janssen-Cilag International NV, a Johnson & Johnson company,
received a positive opinion from the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency
recommending an extension of marketing authorisation for a
subcutaneous (SC) formulation of RYBREVANT® (amivantamab) in
combination with LAZCLUZE® (lazertinib) for the first-line
treatment of adult patients with advanced non-small cell lung
cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19
deletions or exon 21 L858R substitution mutations, and as a
monotherapy for the treatment of adult patients with advanced NSCLC
with activating EGFR exon 20 insertion mutations after failure of
platinum-based therapy.
"We are pleased that the subcutaneous formulation of
amivantamab, which was developed with our ENHANZE drug delivery
technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive
officer of Halozyme. "The data that support the recommendation
could represent a very compelling proposition for patients with the
approximate five-minute administration time and five-fold reduction
in infusion related reactions."
The CHMP positive opinion is supported by positive results from
the Phase 3 PALOMA-3 study (NCT05388669). For more information on
the study and its findings, please view Johnson & Johnson's
press release issued today.
Subcutaneous amivantamab is co-formulated with recombinant human
hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery
technology.
1 Leighl NB et al. Subcutaneous Versus
Intravenous Amivantamab, Both in Combination With Lazertinib, in
Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell
Lung Cancer: Primary Results From the Phase III PALOMA-3 Study.
ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605.
2 Leighl NB, et al. Subcutaneous Versus
Intravenous Amivantamab, Both in Combination With Lazertinib, in
Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell
Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J
Clin Oncol. 2024 Oct 20;42(30):3593-3605.
3 ClinicalTrials.gov. A Study of Lazertinib With
Subcutaneous Amivantamab Compared With Intravenous Amivantamab in
Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated
Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3).
https://clinicaltrials.gov/ct2/show/NCT05388669. Accessed
January 2025.
About Halozyme
Halozyme is a biopharmaceutical company advancing disruptive
solutions to improve patient experiences and outcomes for emerging
and established therapies. As the innovators of ENHANZE® drug
delivery technology with the proprietary enzyme rHuPH20, Halozyme's
commercially-validated solution is used to facilitate the
subcutaneous delivery of injected drugs and fluids, with the goal
of improving the patient experience with rapid subcutaneous
delivery and reduced treatment burden. Having touched one million
patient lives in post-marketing use in nine commercialized products
across more than 100 global markets, Halozyme has licensed its
ENHANZE® technology to leading pharmaceutical and biotechnology
companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli
Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai
Pharmaceutical and Acumen Pharmaceuticals.
Halozyme also develops, manufactures and commercializes, for
itself or with partners, drug-device combination products using its
advanced auto-injector technologies that are designed to provide
commercial or functional advantages such as improved convenience,
reliability and tolerability, and enhanced patient comfort and
adherence. The Company has two commercial proprietary products,
Hylenex® and XYOSTED®, partnered commercial products and ongoing
product development programs with Teva Pharmaceuticals and Idorsia
Pharmaceuticals.
Halozyme is headquartered in San
Diego, CA and has offices in Ewing, NJ and Minnetonka, MN. Minnetonka is also the site of its operations
facility.
For more information visit www.halozyme.com and connect with us
on LinkedIn and Twitter.
Safe Harbor Statement
In addition to historical information, the statements set forth
above include forward-looking statements including, without
limitation, statements concerning the possible activity, benefits
and attributes of ENHANZE®, the possible method of action of
ENHANZE®, its potential application to aid in the dispersion and
absorption of other injected therapeutic drugs, and statements
concerning certain other potential benefits of ENHANZE® including
facilitating more rapid delivery of injectable medications through
subcutaneous delivery and potentially lowering the treatment burden
for patients, including a potential reduction in administration
time and infusion related reactionsand broadening the treatment
options for the indications referred to in this press release.
Forward-looking statements may also include statements regarding
the product development efforts of Halozyme's ENHANZE® partner and
the potential approval of an extension of marketing authorization
for the subcutaneous formulation referred to in this press
release. These forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially
from those in the forward-looking statements. The forward-looking
statements are typically, but not always, identified through use of
the words "expect," "believe," "enable," "may," "will," "could,"
"intends," "estimate," "anticipate," "plan," "predict," "probable,"
"potential," "possible," "should," "continue," and other words of
similar meaning. Actual results could differ materially from the
expectations contained in forward-looking statements as a result of
several factors, including uncertainties concerning whether the
extension of marketing authorization for the subcutaneous
formulation referred to in this press release is ultimately
approved, unexpected results or delays in the launch or
commercialization of our partner's product for the indication
referred to in this press release, unexpected adverse events or
patient experiences or outcomes from being treated with the
ENHANZE® co-formulated treatment referred to in this press release,
and competitive conditions. These and other factors that may result
in differences are discussed in greater detail in Halozyme's most
recent Annual and Quarterly Reports filed with the Securities and
Exchange Commission. Except as required by law, Halozyme undertakes
no duty to update forward-looking statements to reflect events
after the date of this release.
Contacts:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com
Samantha Gaspar
Teneo
212-886-9356
samantha.gaspar@teneo.com
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SOURCE Halozyme Therapeutics, Inc.