FDA foresees jump in apps for cancer drugs

U.S. regulators expect to review lots of cancer drugs this year. With developers finding ways to get early readouts on efficacy, companies are expediting programs to set the stage for rapid development and speedy approvals of new anti-cancer therapies. In an interview with Reuters, FDA oncology chief Dr. Richard Pazdur predicts that the agency will receive 20 submissions for cancer drugs in 2012.

It's too early to tell whether that will lead to an increase in approvals this year, but the number says a lot about intense participation in cancer drug research around the biopharma industry. The FDA has only fueled activity in oncology with its growing track record of green-lighting cancer drugs in short order when the treatments show evidence of benefiting patients with life-threatening malignancies. A recent example was the agency's approval last summer of Seattle Genetics' ($SGEN) lymphoma drug Adcetris based on small, single-arm studies with impressive results.

"It is much easier to approve drugs that have greater efficacy," Pazdur told Reuters. "Our staff is interested getting the drugs out earlier ... it has to be [a] drug that we really think is important."

As Reuters notes, a third of the 30 new drugs approved last year in the U.S. were cancer treatments. What's behind the numbers? For one, researchers have drilled deeper into the biology of cancer, uncovering a wealth of disease-related gene targets that can be bull's-eyed with new drugs, and patients can be screened for the genes before they get the treatments. Developers have been able to move fast in the clinic with targeted cancer drugs and seek approvals earlier than they could for treatments against other diseases.

Rather than the standard decade-long development timeline for drugs, companies have been able to jump from initial human studies to regulatory submissions for cancer meds in just a few years. Take GlaxoSmithKline's ($GSK) experimental melanoma drugs for patients with BRAF mutations. As FierceBiotech's John Carroll reported Monday, the London-based drug giant expects to file for U.S. and European approvals of the pair of targeted drugs later this year, little more than three years after kicking off early-stage studies of the treatments.

"It has been the fastest experience of my entire career," Paolo Paoletti, the president of GSK Oncology, said in the interview.

Pazdur makes clear in his Reuters interview that the FDA pays special attention to game-changing therapies. And in recent weeks U.S. lawmakers have backed proposals to give the agency the flexibility to use a variety of tools to fast-track programs for drugs against serious and deadly diseases. In oncology, there are plenty such cases.

- read the Reuters article

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