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.
The regulator approved the CLL medication Friday, giving the drugmaker time to create a marketing transition before Rituxan goes generic. The approval marks another milestone: the first drug approved with a Breakthrough Designation label, a tag that is now coming under scrutiny.
Complete Response letter slows Merck's suggamedex; AbbVie looks for next Humira; Roche drug gets breakthrough label; FDA effort to better track medical devices
BI cancer drug lands breakthrough therapy designation; Sanofi tallies two European MS drug approvals; GSK terminates testing for a Crohn's drug; and Teva joins cancer collaboration
GlaxoSmithKline heats up the CLL category with its second breakthrough designation therapy of the year, topped off by priority review for a melanoma combo treatment.
FDA is concerned state biosimilar legislation could make consumers uneasy about the category, J&J hands $75 million milestone payment for ibrutinib, Consumer Reports gets into drug apps
Takeda moves an Alzheimer's treatment to Phase III; Sangamo acquires Ceregene; Catalyst gets breakthrough designation for auto-immune disorder drug; study says seniors likely to opt out of health insurance
The drug maker scored its third breakthrough designation label, this time for orphan drug bimagrumab, a possible treatment for a muscle-wasting disease.
Glaxo shakes up China division, Teva and Lonza break up their biosimilars pact, and FDA's breakthrough designation speeds review but not international and payer uptake.
The interim results of a Phase III study augur well for use of Roche's Rituxan successor in more than one type of leukemia, one analyst said.
The FDA's priority review for the Phase III chronic lymphocytic leukemia drug comes on top of Breakthrough Therapy designation, which the agent won in May.
Arena gets closer to the market place, Takeda scoops up privately held Inviragen, Plan B court decision is coming and Cubist antibotic lands breakthrough therapy status.
Lantus cushions Sanofi's quarterly sales; Allergan holds back on Eylea competitor; FDA limits use of Otsuka drug; Genmab lands Breakthrough label; NIH finds a link among cancers; and Novartis offers lunch with a side of medical information; DOJ appeals Plan-B Ruling.
Health-seeking consumers continue social-media push; Scioderm scores FDA's "Breakthrough" designation for bullosa agent; and GSK files NDA for airway treatment.