Cancer drug developers are blazing a faster, cheaper path to approval
Historically, the business of developing new cancer drugs has been a devastating chronicle of repeated failure.
BIO analysts recently noted that only about one out of every 20 new oncology candidates went on to an approval in the past decade, and that 5% success ratio could have been overly generous. But as a pair of Reuters scribes note in a lengthy feature today, improvements in sequencing combined with much better insights on the biologic pathways of cancer and advances in diagnostics have combined to dramatically improve the odds of success while promising significantly shorter programs at a much lower cost.
"You can cut a couple of years out of the clinical trial process by basically doing your pivotal trial straight from Phase I," Richard Scheller, Genentech's head of early stage research, tells Bill Berkrot and Ransdell Pierson. That's because Phase I is no longer limited to safety and dose. Now early-stage studies also frequently include the kind of proof-of-concept data that developers had waited to scout for in Phase II.
"What we're looking at many times is Phase I data where we're seeing levels of response that we haven't seen before in patients that have exhausted most of the therapies in a disease," said FDA's Dr. Richard Pazdur. And the chance of taking breakthrough drugs directly to patients with advanced, metastatic cases will likely make this field the biggest beneficiary of new regulations designed to fast-track preliminary approvals.
As Hal Barron, the head of research for Roche/Genentech, recently told FierceBiotech, one of the big hurdles ahead is finding out now why patients start to fail to respond to their therapy. That research effort will deliver new combo approaches that can further extend survival rates for the sickest patients while offering new hope to early-stage cases.
But don't expect less expensive clinical programs to lead to lower-cost drugs. "I would hope it would bring down the cost of drugs, but whatever the market bears is what the market will get," Robert Schneider, director of translational cancer research at New York University Cancer Institute, tells Reuters.
- here's the article from Reuters
FDA: 'Breakthrough' designation allows for drug approval on PhI data
Roche, pharma slice and dice DNA data to exploit cancer weaknesses
Pfizer nabs another targeted cancer drug OK from FDA
Regulators start thinking creatively about new approval pathway
New cancer drugs debut faster in U.S., but they cost more