Despite warnings, FDA approves new Novartis AG cancer drug

Despite warnings, FDA approves new Novartis AG cancer drug

Although an advisory panel advised against it, the US Food and Drug Administration has approved Novartis AG’s cancer drug, Farydak.

Meant to treat patients who’ve relapsed with multiple myeloma, an aggressive blood cancer that affects plasma cells in the bone marrow, Farydak was approved on Monday despite an advisory board recommending against it in November.

The Basal-based drug company announced the FDA approved Farydak for use in combination with Takeda Velcade and dexamethasone after a patient has received two prior treatments of Velcade and an immunomodulatory drug.

Farydak has shown promise in slowing the progression of the disease by almost half the time when compared to patients who receive standard treatment. Clinical test results showed that the combination drug therapy gave patients 10.6 months with no worsening of their disease.

The company says their studies show that just under 60 percent of patients saw their cancer shrink or disappear, compared to 41 percent for patients undergoing traditional treatments. The side effects, however, can range from heart problems to severe diarrhea.

Medical experts outside the FDS’s advisory panel voted 5 to 2 against recommending the Swiss pharmaceutical giant’s drug combination for approval, siting the benefits did not outweigh the risks.

Farydak is the first in a new class of treatments called HDAC inhibitors designed to restore cell function for patients with multiple myeloma. Novartis said Farydak is under review for approval by health authorities in Japan and the European Union.