The Food and Drug Administration said Friday it granted full approval to AbbVie and ImmunoGen’s cancer drug mirvetuximab-soravtansine-gynx, or Elahere, part of a new class of cancer treatments considered “biological missiles” because of their ability to precisely home in on cancer cells.
FILE - A sign for the U.S. Food and Drug Administration is displayed outside their offices in Silver ... [+]
Elahere is now approved for patients with a specific type of cancer in the ovaries, fallopian tubes or peritoneum who have already received one to three prior treatment regimens, the FDA said.
Patients with these cancers often undergo surgery and then receive platinum-based chemotherapy, but may become resistant to that treatment, requiring a new therapy like Elahere, AbbVie said in a press release.
The FDA granted an accelerated approval to the drug in 2022, but granted this full, traditional approval based on the results of a study completed in 2023 that found patients taking Elahere were 35% less likely to die or see tumor progression when taking the drug compared to other chemotherapies, and had lower rates of serious adverse events.
Still, the drug contains a so-called boxed warning, representing the strongest warning the FDA can give, noting Elahere can cause severe eye problems, including visual impairment, dry eye, eye pain and other adverse reactions—ocular adverse effects occurred in 59% of patients treated with Elahere, AbbVie says.
Elahere is an “antibody-drug conjugate,” a type of cancer drug known for its precise targeting of cancer cells that one 2022 study said was “leading a new era of targeted cancer therapy.” According to the American Cancer Society, Elahere contains an antibody that “acts like a homing device” by attaching to protein that is found in high-levels in ovarian cancer cells.
Elahere was developed by ImmunoGen, but became part of AbbVie’s portfolio after AbbVie acquired ImmunoGen for $10 billion last November. AbbVie’s purchase of ImmunoGen and Elahere specifically was widely seen as, in part, an attempt to find a new drug to bolster its portfolio after it lost exclusivity to its successful arthritis medication Humira, and low-cost rivals flooded the market. Humira was considered the best-selling drug in the world.
When the drug received accelerated approval, the American Association for Cancer Research noted it was a milestone in the treatment of the specific “platinum-resistant” ovarian cancer that the drug targets, which generally has a “poor prognosis.” The Association said it was the first antibody-drug conjugate ever approved for platinum-resistant ovarian cancer, and the first approval in general for any drug targeting platinum-resistant ovarian cancer since 2014.