ImmunoGen Submits Biologics License Application to the US Food and Drug Administration for Mirvetuximab Soravtansine in Ovarian Cancer
March 29 2022 - 6:30AM
Business Wire
Submission Based on Positive Results from Pivotal Phase 3 SORAYA
Trial
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that it has submitted a Biologics License
Application (BLA) under the accelerated approval pathway to the US
Food and Drug Administration (FDA) for mirvetuximab soravtansine
monotherapy in patients with folate receptor alpha (FRα)-high
platinum-resistant ovarian cancer who have been previously treated
with 1 to 3 prior systemic treatments. The submission is based on
results from the pivotal Phase 3 SORAYA trial. Top-line data from
SORAYA were announced in November 2021 and full data from the study
were presented this month at the Society of Gynecologic Oncology
(SGO) 2022 Annual Meeting.
“The BLA submission for mirvetuximab soravtansine is a key
inflection point on our journey to delivering a safe and effective
treatment option to patients with platinum-resistant ovarian cancer
and moves us one step closer to transforming ImmunoGen into a
fully-integrated oncology company,” said Mark Enyedy, ImmunoGen’s
President and Chief Executive Officer. “Platinum-resistant ovarian
cancer is an area with high unmet need, and we look forward to
working with FDA to secure mirvetuximab soravtansine’s first
approval and bringing this novel therapy to patients as quickly as
possible.”
The FDA has a 60-day review period to determine whether the BLA
is complete and acceptable for filing. ImmunoGen has requested
priority review of the application and, if granted, the review will
be completed within six months of the filing date. The BLA was
submitted under the FDA’s accelerated approval pathway, instituted
to allow for expedited development of drugs that treat serious
conditions and provide a meaningful advantage over available
therapies based on a surrogate endpoint. ImmunoGen continues to
enroll patients in the confirmatory MIRASOL trial designed to
generate the randomized data needed for full approval and expects
to announce top-line data from this study in the third quarter of
2022.
The FDA granted Orphan Drug Designation to mirvetuximab
soravtansine for the treatment of ovarian cancer in April 2015. In
June 2018, the FDA granted mirvetuximab soravtansine Fast Track
Designation for the treatment of patients with medium to high
FRα-positive platinum-resistant ovarian cancer who received at
least one, but no more than three, prior systemic treatment
regimens, and for whom single-agent chemotherapy is appropriate as
the next line of therapy. This designation is intended to
facilitate the development and expedite the review of drugs that
treat serious and life-threatening conditions.
ABOUT MIRVETUXIMAB SORAVTANSINE Mirvetuximab soravtansine
(IMGN853) is a first-in-class ADC comprising a folate receptor
alpha-binding antibody, cleavable linker, and the maytansinoid
payload DM4, a potent tubulin-targeting agent, to kill the targeted
cancer cells.
ABOUT IMMUNOGEN ImmunoGen is developing the next
generation of antibody-drug conjugates (ADCs) to improve outcomes
for cancer patients. By generating targeted therapies with enhanced
anti-tumor activity and favorable tolerability profiles, we aim to
disrupt the progression of cancer and offer our patients more good
days. We call this our commitment to TARGET A BETTER NOW™.
Learn more about who we are, what we do, and how we do it at
www.immunogen.com.
FORWARD-LOOKING STATEMENTS This press release includes
forward-looking statements. These statements include, but are not
limited to, ImmunoGen’s expectations related to: the occurrence,
timing, and outcome of potential clinical and regulatory events
related to the Company’s product candidates, including the review
of the Company’s BLA to the FDA for mirvetuximab and full approval
of mirvetuximab; and the presentation of preclinical and clinical
data on the Company’s product candidates, including top-line data
from the MIRASOL trial in the third quarter of 2022. Various
factors could cause ImmunoGen’s actual results to differ materially
from those discussed or implied in the forward-looking statements,
and you are cautioned not to place undue reliance on these
forward-looking statements, which are current only as of the date
of this release. Factors that could cause future results to differ
materially from such expectations include, but are not limited to:
the timing and outcome of the Company’s preclinical and clinical
development processes; the difficulties inherent in the development
of novel pharmaceuticals, including uncertainties as to the timing,
expense, and results of preclinical studies, clinical trials, and
regulatory processes; the Company’s ability to financially support
its product programs; the timing and outcome of the Company’s
anticipated interactions with regulatory authorities, including
that the FDA may determine that our BLA for mirvetuximab does not
meet the conditions for accelerated approval; risks and
uncertainties associated with the scale and duration of the
COVID-19 pandemic and the resulting impact on ImmunoGen’s industry
and business; and other factors as set forth in the Company’s
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on February 28, 2022, and other reports filed with the
Securities and Exchange Commission.
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INVESTOR RELATIONS AND MEDIA CONTACTS ImmunoGen Courtney
O’Konek 781-895-0600 courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
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