The FDA granted Breakthrough Therapy status to the duo’s multiple myeloma treatment.
The FDA announced Tuesday its approval of lung cancer drug Zykadia for patients with metastatic ALK-positive non-small cell lung cancer.
The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.
The FDA granted Breakthrough status to the daclatasvir + asunaprevir combo for hepatitis C patients with genotype 1b.
Researchers say it’s too early to declare the 2012 program a success but that the label will benefit drugs beyond those with orphan status.
Reports are that the UK wants an expedited process that will mirror the FDA’s.
It was granted based on data among patients with BRAF V600E mutation-positive non-small lung cancer who have undergone chemo.
The FDA’s Center for Drug Evaluation and Research released a preliminary year-in-review report that says the agency has cleared 26 new molecular entities this year.
The drug is priced at $28,000 a month, before add-ons like ribavirin and (possibly) interferon.
The company also has breakthrough therapy designations for CLL and Waldenstrom’s macroglobulinemia.
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