ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field
of antibody-drug conjugates (ADCs) for the treatment of cancer,
today announced that the European Medicines Agency (EMA) has
accepted the Marketing Authorization Application (MAA) for
mirvetuximab soravtansine (ELAHERE®) for the treatment of patients
with folate receptor alpha (FRα)-positive, platinum-resistant
epithelial ovarian, fallopian tube, or primary peritoneal
cancer.
"The acceptance of our MAA is another important regulatory
milestone in the next chapter of ELAHERE’s story as we work
diligently to deliver this new treatment option to patients with
platinum-resistant ovarian cancer globally," said Michael
Vasconcelles, MD, ImmunoGen's Executive Vice President, Research,
Development, and Medical Affairs. "As the first novel medicine to
have demonstrated an overall survival benefit in platinum-resistant
ovarian cancer compared to chemotherapy in a Phase 3 clinical
trial, we are pleased to initiate the review process that moves us
one step closer to providing access to ELAHERE for eligible
patients in Europe. We look forward to working closely with the EMA
throughout the review process and to potentially bring this novel
ADC to Europe as early as 2024."
The MAA is supported by positive data from the Phase 3 MIRASOL
trial of ELAHERE in platinum-resistant ovarian cancer, which was
disclosed in May 2023 and subsequently presented as a late-breaking
abstract at the 2023 American Society of Clinical Oncology Annual
Meeting. In the MIRASOL trial, ELAHERE demonstrated statistically
significant and clinically meaningful improvements in
progression-free survival, objective response rate, and overall
survival compared to investigator's choice (IC) of single-agent
chemotherapy. ELAHERE demonstrated a tolerable safety profile
compared to IC chemotherapy consisting predominantly of low-grade
ocular and gastrointestinal events.
ELAHERE was approved by the US Food and Drug Administration in
November 2022.
ABOUT OVARIAN CANCER
Ovarian cancer is the leading cause of death from gynecological
cancers worldwide. Each year, more than 66,000 patients are
diagnosed and 45,000 patients will die in the United States and
Europe combined. Most patients present with late-stage disease and
will typically undergo surgery followed by platinum-based
chemotherapy. Unfortunately, the majority of patients eventually
develop platinum-resistant disease, which is difficult to
treat.
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.
ABOUT ELAHERE (MIRVETUXIMAB SORAVTANSINE)
ELAHERE (mirvetuximab soravtansine-gynx) is a first-in-class ADC
comprising a folate receptor alpha-binding antibody, cleavable
linker, and the maytansinoid payload DM4, a potent tubulin
inhibitor designed to kill the targeted cancer cells.
ELAHERE is indicated for the treatment of adult patients with
folate receptor-alpha (FRα) positive, platinum-resistant epithelial
ovarian, fallopian tube, or primary peritoneal cancer, who have
received one to three prior systemic treatment regimens. Select
patients for therapy based on an FDA-approved test. This indication
is approved under accelerated approval based on tumor response rate
and durability of response. Continued approval for this indication
may be contingent upon verification and description of clinical
benefit in a confirmatory trial.
The prescribing information includes a boxed warning. ELAHERE
can cause severe ocular toxicities, including visual impairment,
keratopathy, dry eye, photophobia, eye pain, and uveitis. Conduct
an ophthalmic exam including visual acuity and slit lamp exam prior
to initiation of ELAHERE, every other cycle for the first 8 cycles,
and as clinically indicated. Administer prophylactic artificial
tears and ophthalmic topical steroids. Withhold ELAHERE for ocular
toxicities until improvement and resume at the same or reduced
dose. Discontinue ELAHERE for Grade 4 ocular toxicities.
Serious adverse reactions occurred in 31% of patients. The most
common (≥2%) serious adverse reactions were intestinal obstruction
(8%), ascites (4%), infection (3%), and pleural effusion (3%).
Fatal adverse reactions occurred in 2% of patients, including small
intestinal obstruction (1%) and pneumonitis (1%).The most common
(≥20%) adverse reactions, including laboratory abnormalities, were
vision impairment, fatigue, increased aspartate aminotransferase,
nausea, increased alanine aminotransferase, keratopathy, abdominal
pain, decreased lymphocytes, peripheral neuropathy, diarrhea,
decreased albumin, constipation, increased alkaline phosphatase,
dry eye, decreased magnesium, decreased leukocytes, decreased
neutrophils, and decreased hemoglobin.
Please see full Prescribing Information, including Boxed Warning
for ELAHERE.
FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. These
statements include, but are not limited to, the Company's
expectations related to the EMA review process and the outcome of
the Marketing Authorization Application for mirvetuximab
soravtansine in Europe. 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
regulatory processes; the timing and outcome of the Company's
anticipated interactions with regulatory authorities; and other
factors as set forth in the Company's Annual Report on Form 10-K
filed with the Securities and Exchange Commission on March 1, 2023,
the Company's Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on April 28, 2023 and July 31,
2023, and other reports filed with the Securities and Exchange
Commission. The forward-looking statements in this press release
speak only as of the date of this press release. ImmunoGen
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future developments, or
otherwise, except as may be required by applicable law.
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version on businesswire.com: https://www.businesswire.com/news/home/20231027222159/en/
INVESTOR RELATIONS ImmunoGen Anabel Chan 781-895-0600
anabel.chan@immunogen.com
MEDIA ImmunoGen Courtney O'Konek 781-895-0600
courtney.okonek@immunogen.com
OR
FTI Consulting Robert Stanislaro 212-850-5657
robert.stanislaro@fticonsulting.com
ImmunoGen (NASDAQ:IMGN)
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