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.
Novartis believes its new oncology treatment can make a major difference for patients with multiple myeloma, a blood cancer with a particularly grim prognosis. But first it'll have to convince a group of independent experts that the drug's ability to extend survival by a few months outweighs a significant increase in safety risks.
Denmark's Genmab is rolling right along with breakthrough-designated daratumumab for double refractory multiple myeloma, hitting a milestone in Phase II development and triggering a $22 million payout from collaborator Johnson & Johnson.
Novartis' in-development multiple myeloma candidate LBH589 hit its primary endpoint of staving off cancer progression in a late-stage study, the company said, stoking hopes the Swiss drugmaker can take first place among a new class of treatments.