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.
The National Institute for Health and Care Excellence nixed Johnson & Johnson's Velcade as too expensive in comparison with the current standard therapies--at least as far as the current data can show.
The money will be used, in part, to pay for a mid-stage study of MOR208, its anti-CD19 antibody for chronic lymphocytic leukemia as well as new studies of MOR202, an anti-CD38 antibody currently in a Phase I/IIa clinical trial in multiple myeloma.
Multiple myeloma, one of the most common types of blood cancer, has been linked to a gene that's responsible for regulating the aging process in the human body.