Lymphoma
The company will push through with an accelerated approval application for odronextamab in follicular lymphoma, leaving diffuse large B cell lymphoma behind.
Leaked data showed that Pfizer’s mevrometostat has strong therapeutic potential in metastatic castration-resistant prostate cancer, while recent readouts also position the pharma as a strong contender in colorectal cancer and bladder cancer.
Adding a new indication for the CAR T cell therapy could help BMS offset the loss-of-exclusivity headwinds it faces in the coming years.
The conversion of Calquence’s accelerated approval in mantle cell lymphoma comes a day before the drug was listed among the 15 products to be subject to IRA-prescripted price negotiations for Medicare this year.
Both vibostolimab and favezelimab have had disappointing runs leading up to their termination, sustaining several late-stage failures.
Analysts called the data “very competitive” but raised questions about safety. Merck gained ownership of the ADC when it acquired VelosBio in November 2020 for $2.75 billion.
Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
With the FDA’s rejection of Ordspono in March, Monday’s green light from the European Commission marks the first approval worldwide and the first regulatory victory for Regeneron’s bispecific antibody platform.
Two months after winning FDA approval in the same indication, AbbVie and Genmab on Monday secured the European Commission’s nod for its bispecific antibody Tepkinly for the most common type of low-grade non-Hodgkin lymphoma.
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