NORTH
CHICAGO, Ill., Sept. 20,
2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the European Medicines Agency's (EMA) Committee for
Medicinal Products for Human Use (CHMP) has adopted a positive
opinion recommending the marketing authorization of mirvetuximab
soravtansine (ELAHERE®) for the treatment of adult
patients with folate receptor alpha (FRα)-positive,
platinum-resistant and high-grade serous epithelial ovarian,
fallopian tube or primary peritoneal cancer who have received one
to three prior treatment regimens. Patients with ovarian cancer are
often diagnosed with late-stage disease, undergo surgery and are
then primarily treated with platinum-based chemotherapy. Over time
patients may become resistant to platinum-based treatment and will
require another therapy. The CHMP's opinion is supported by results
of the Phase 3 MIRASOL clinical trial and the European Commission
decision on this indication for mirvetuximab soravtansine is
anticipated later this year.
"Following many years of development by the ImmunoGen team that
is now part of AbbVie, we are hopeful to make mirvetuximab
soravtansine available to eligible patients with ovarian cancer in
the European Union. This positive opinion recognizes the unmet need
for certain patients with platinum-resistant ovarian cancer,"
said Roopal Thakkar, M.D., executive vice president, research
and development, chief scientific officer, AbbVie.
ELAHERE® (mirvetuximab soravtansine-gynx) was granted full
FDA approval in the United States in March 2024.
Marketing authorization submissions for mirvetuximab soravtansine
are under review in multiple other countries.
ABOUT THE PHASE 3 MIRASOL TRIAL
MIRASOL is a global Phase 3 open-label, randomized, controlled
trial that enrolled 453 patients to compare the efficacy and safety
of mirvetuximab soravtansine with the investigator's choice of
single-agent chemotherapy (weekly paclitaxel, pegylated liposomal
doxorubicin, or topotecan) in the treatment of platinum-resistant,
high-grade serous ovarian cancer whose tumors express high levels
of FRα (≥75% of cells with ≥2+ staining intensity). Participants
had previously received one to three lines of prior therapy. The
primary endpoint was investigator-assessed progression-free
survival (PFS). Key secondary endpoints included objective response
rate (ORR) and overall survival (OS).
Results of the study were previously shared in June 2023. More information can be found on
www.clinicaltrials.gov (NCT 04209855).
About Ovarian Cancer
Ovarian cancer is one of the leading causes of death from
gynecological cancers. According to the World Ovarian Cancer
Coalition, in 2022 more than 320,000 women worldwide were diagnosed
with ovarian cancer. By 2050 the annual incidence will have risen
to nearly half a million, an increase of 55 percent. 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. In this setting, standard of care
single-agent chemotherapies are associated with decreased efficacy
and tolerability.
About Mirvetuximab Soravtansine
Mirvetuximab soravtansine 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.
Mirvetuximab soravtansine is not approved in the EU.
ELAHERE® (mirvetuximab soravtansine-gynx) U.S. INDICATION and
IMPORTANT SAFETY INFORMATION
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.
IMPORTANT SAFETY INFORMATION
WARNING: OCULAR TOXICITY
- 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.
WARNINGS and PRECAUTIONS
Ocular Disorders
ELAHERE can cause severe ocular adverse reactions, including visual
impairment, keratopathy (corneal disorders), dry eye, photophobia,
eye pain, and uveitis.
Ocular adverse reactions occurred in 59% of patients with
ovarian cancer treated with ELAHERE. Eleven percent (11%) of
patients experienced Grade 3 ocular adverse reactions, including
blurred vision, keratopathy (corneal disorders), dry eye, cataract,
photophobia, and eye pain; two patients (0.3%) experienced Grade 4
events (keratopathy and cataract). The most common (≥5%) ocular
adverse reactions were blurred vision (48%), keratopathy (36%), dry
eye (27%), cataract (16%), photophobia (14%), and eye pain
(10%).
The median time to onset for first ocular adverse reaction was
5.1 weeks (range: 0.1 to 68.6). Of the patients who experienced
ocular events, 53% had complete resolution; 38% had partial
improvement (defined as a decrease in severity by one or more
grades from the worst grade at last follow up). Ocular adverse
reactions led to permanent discontinuation of ELAHERE in 1% of
patients.
Premedication and use of lubricating and ophthalmic topical
steroid eye drops during treatment with ELAHERE are recommended.
Advise patients to avoid use of contact lenses during treatment
with ELAHERE unless directed by a healthcare
provider.
Refer patients to an eye care professional for an ophthalmic
exam including visual acuity and slit lamp exam prior to treatment
initiation, every other cycle for the first 8 cycles, and as
clinically indicated. Promptly refer patients to an eye care
professional for any new or worsening ocular signs and
symptoms.
Monitor for ocular toxicity and withhold, reduce, or permanently
discontinue ELAHERE based on severity and persistence of ocular
adverse reactions.
Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD),
including pneumonitis, can occur in patients treated with
ELAHERE.
Pneumonitis occurred in 10% of patients treated with ELAHERE,
including 1% with Grade 3 events and 1 patient (0.1%) with a Grade
4 event. One patient (0.1%) died due to respiratory failure in the
setting of pneumonitis and lung metastases. One patient (0.1%) died
due to respiratory failure of unknown etiology. Pneumonitis led to
permanent discontinuation of ELAHERE in 3% of patients.
Monitor patients for pulmonary signs and symptoms of
pneumonitis, which may include hypoxia, cough, dyspnea, or
interstitial infiltrates on radiologic exams. Infectious,
neoplastic, and other causes for such symptoms should be excluded
through appropriate investigations. Withhold ELAHERE for patients
who develop persistent or recurrent Grade 2 pneumonitis until
symptoms resolve to ≤ Grade 1 and consider dose reduction.
Permanently discontinue ELAHERE in all patients with Grade 3 or 4
pneumonitis. Patients who are asymptomatic may continue dosing of
ELAHERE with close monitoring.
Peripheral Neuropathy (PN)
Peripheral neuropathy occurred in 36% of patients with ovarian
cancer treated with ELAHERE across clinical trials; 3% of patients
experienced Grade 3 peripheral neuropathy. Peripheral neuropathy
adverse reactions included peripheral neuropathy (20%), peripheral
sensory neuropathy (9%), paraesthesia (6%), neurotoxicity (3%),
hypoaesthesia (1%), peripheral motor neuropathy (0.9%),
polyneuropathy (0.3%), and peripheral sensorimotor neuropathy
(0.1%). Monitor patients for signs and symptoms of neuropathy, such
as paresthesia, tingling or a burning sensation, neuropathic pain,
muscle weakness, or dysesthesia. For patients experiencing new or
worsening PN, withhold dosage, dose reduce, or permanently
discontinue ELAHERE based on the severity of PN.
Embryo-Fetal Toxicity
Based on its mechanism of action, ELAHERE can cause embryo-fetal
harm when administered to a pregnant woman because it contains a
genotoxic compound (DM4) and affects actively dividing
cells.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use effective contraception
during treatment with ELAHERE and for 7 months after the last
dose.
ADVERSE REACTIONS
The most common (≥20 %) adverse reactions, including lab
abnormalities, were increased aspartate aminotransferase, fatigue,
increased alanine aminotransferase, blurred vision, nausea,
increased alkaline phosphatase, diarrhea, abdominal pain,
keratopathy, peripheral neuropathy, musculoskeletal pain, decreased
lymphocytes, decreased platelets, decreased magnesium, decreased
hemoglobin, dry eye, constipation, decreased leukocytes, vomiting,
decreased albumin, decreased appetite, and decreased
neutrophils.
DRUG INTERACTIONS
DM4 is a CYP3A4 substrate. Closely monitor patients for adverse
reactions with ELAHERE when used concomitantly with strong CYP3A4
inhibitors.
USE IN SPECIAL POPULATIONS
Lactation
Advise women not to breastfeed during treatment with ELAHERE and
for 1 month after the last dose.
Hepatic Impairment
Avoid use of ELAHERE in patients with moderate or severe hepatic
impairment (total bilirubin >1.5 ULN).
Please see full Prescribing Information,
including BOXED WARNING
About AbbVie in Oncology
At AbbVie, we are committed
to transforming standards of care for patients living with
difficult-to-treat cancers. We are advancing a dynamic pipeline of
investigational therapies across a range of cancer types in both
blood cancers and solid tumors. We are focusing on creating
targeted medicines that either impede the reproduction of cancer
cells or enable their elimination. We achieve this through various,
targeted treatment modalities including Antibody Drug Conjugates
(ADCs), Immuno-Oncology, bi-specific antibody and CAR-T
platforms. Our dedicated and experienced team joins forces
with innovative partners to accelerate the delivery of potential
breakthrough medicines.
Today, our expansive oncology portfolio comprises of approved
and investigational treatments for a wide range of blood and solid
tumors. We are evaluating more than 20 investigational medicines in
multiple clinical trials across some of the world's most widespread
and debilitating cancers. As we work to have a remarkable impact on
people's lives, we are committed to exploring solutions to help
patients obtain access to our cancer medicines. For more
information, please visit http://www.abbvie.com/oncology.
About AbbVie
AbbVie's mission is to discover and
deliver innovative medicines and solutions that solve serious
health issues today and address the medical challenges of tomorrow.
We strive to have a remarkable impact on people's lives across
several key therapeutic areas – immunology, oncology, neuroscience,
and eye care – and products and services in our Allergan Aesthetics
portfolio. For more information about AbbVie, please visit us at
www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X
(formerly Twitter), and YouTube.
Forward-Looking Statements
Some statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions and uses of future
or conditional verbs, generally identify forward-looking
statements. AbbVie cautions that these forward-looking statements
are subject to risks and uncertainties that may cause actual
results to differ materially from those expressed or implied in the
forward-looking statements. Such risks and uncertainties include,
but are not limited to, challenges to intellectual property,
competition from other products, difficulties inherent in the
research and development process, adverse litigation or government
action, and changes to laws and regulations applicable to our
industry. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2023 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation, and specifically declines, to release publicly any
revisions to forward-looking statements as a result of subsequent
events or developments, except as required by law.
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