ImmunoGen Announces Acceptance of Biologics License Application for Mirvetuximab Soravtansine in Ovarian Cancer by US Food and Drug Administration with Priority Review
May 23 2022 - 5:30AM
Business Wire
PDUFA Date is November 28, 2022
ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the US Food and Drug Administration (FDA) has
accepted and filed the Biologics License Application (BLA) 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 application has been granted Priority Review designation and
FDA has set a Prescription Drug User Fee Act (PDUFA) action date of
November 28, 2022.
“FDA’s acceptance of our BLA under Priority Review reinforces
our belief in the potential for mirvetuximab soravtansine to serve
as a new standard of care for patients with FRα-high
platinum-resistant ovarian cancer,” said Mark Enyedy, ImmunoGen’s
President and Chief Executive Officer. “We are pleased to be one
step closer to realizing the promise of our technology and are
working closely with FDA to support the evaluation of our
application. We are moving quickly to build out the commercial and
medical infrastructure required for a successful launch and look
forward to the prospect of delivering mirvetuximab soravtansine to
patients later this year.”
Priority Review designation is granted to applications for
therapies that may offer significant improvements in the safety or
effectiveness of the treatment, diagnosis, or prevention of serious
conditions when compared to standard applications and shortens the
FDA review period to six months following acceptance.
The BLA seeks approval of mirvetuximab soravtansine under the
FDA’s accelerated approval pathway, which was 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 and 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 at the
Society of Gynecologic Oncology (SGO) 2022 Annual Meeting.
ImmunoGen continues to enroll patients in the confirmatory MIRASOL
trial, which is intended to convert the potential accelerated
approval to full approval, and expects to announce top-line data
from this study in early 2023.
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; the commercial launch of mirvetuximab and the
potential of mirvetuximab to serve as a new standard of care for
patients with platinum-resistant ovarian cancer; and the
presentation of preclinical and clinical data on the Company’s
product candidates, including top-line data from the MIRASOL trial
in early 2023. 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; 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 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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