After scoring FDA approval earlier this year, Novartis' multiple myeloma med Farydak (panobinostat) is picking up steam across the pond, snagging the European Medicines Agency's (EMA) recommendation for patients with advanced forms of the disease.
MorphoSys has released an early look at data from a Phase I/IIa trial of multiple myeloma drug MOR202. While the results are free from major red flags, the publication of Phase II data on Genmab and Johnson & Johnson's rival anti-CD38 drug just days earlier showed the scale of the task now facing MorphoSys.
It was Johnson & Johnson's turn to take center stage at ASCO Saturday morning, fleshing out the promising data that it accumulated in a Phase II study of daratumumab for treatment-resistant multiple myeloma.
The multiple myeloma market already had a couple of meds with third-line nods when the FDA decided to throw a surprise approval into the mix. Can brand-new Farydak from Novartis actually put up a roadblock for Amgen's Kyprolis and Celgene's Pomalyst? That remains to be seen.
The U.K.'s cost-effectiveness gatekeeper is singing an increasingly harsh tune when it comes to greenlighting cancer drugs, and Celgene's Imnovid is the latest med to get a thumbs-down from the watchdog.
Phase II data from Genmab have ratcheted up expectations for a fast-track approval of its Johnson & Johnson-partnered treatment for double refractory multiple myeloma. Analysts see the data as strong enough to bring the CD38 monoclonal antibody to market in the first half of 2016.
Good news for Amgen and its quest to gain a multiple myeloma edge over Celgene's Pomalyst: Results are out from a Phase III Kyprolis trial in patients with relapsed forms of the disease--and investigators say they could crown a new standard of care.
The FDA has branded Takeda's top late-stage drug prospect--ixazomib (MLN9708), a multiple myeloma treatment designed to succeed the top-selling blockbuster Velcade--as a "breakthrough" therapy deserving VIP status with regulators.
The FDA wants more time to deliberate on Novartis' panobinostat, a multiple myeloma treatment that failed to impress a panel of independent experts, signaling a delay that could nearly negate the agency's previous promise of a speedy review.
Novartis' new multiple myeloma is treatment too risky to be approved, a group of FDA advisers voted, dealing a blow to the drugmaker and its hopes of launching the cancer drug next year.