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Ouch! Could There Be A Delay With Fast-Track, FDA Approval For New Anti-Myeloma Drug Carfilzomib?

Home/Research, Supplements/Drugs/Ouch! Could There Be A Delay With Fast-Track, FDA Approval For New Anti-Myeloma Drug Carfilzomib?

Ouch! Could There Be A Delay With Fast-Track, FDA Approval For New Anti-Myeloma Drug Carfilzomib?

I wanted to get this controversial Bloomberg article out to you right away. It’s early, but this doesn’t sound good:

ImmunoGen Cancer Drug Setback May Signal Delays for Onyx, Seattle Genetics

By Ellen Gibson and Catherine Larkin

ImmunoGen Inc.’s failure to win an accelerated U.S. review for its cancer drug sent shares down the most in eight years, and may signal delays for biotechnology companies led by Onyx Pharmaceuticals Inc., analysts say.

ImmunoGen shares plunged $3.23, or 39 percent, to $5.16 at 4 p.m. New York time in Nasdaq Stock Market composite trading after the Food and Drug Administration rejected a request from the company’s partner, Swiss drugmaker Roche Holding AG, to consider clearing the breast-cancer drug trastuzumab-DM1 based on results from mid-stage human trials.

The FDA has reconsidered fast-track approval from three marketed medicines in as many months, suggesting drugmakers may have a harder time getting new treatments cleared until longer, larger human tests are completed, said Jason Kantor, an analyst at RBC Capital Markets. Onyx and Seattle Genetics Inc. have said they will seek drug approvals from early results and may be the next companies delayed by regulators.

Today’s announcement “signals a harder line stance from the FDA against accelerated approval and approvals based on small patient numbers,” Kantor said in a telephone interview. “It’s a symptom of something that’s been going on for a while at the FDA, and it highlights the importance of defining the patient population ahead of time.”

Accelerated approval was authorized in 1992 to help spur development of medicines for HIV. The program allows companies to win conditional marketing clearance of drugs for serious illnesses based on preliminary evidence showing they work. It has been popular for makers of cancer drugs because tumor shrinkage or other physical signs that cancer is being defeated can be measured more quickly than prolonged survival.

Lots more in this article, including update on carfilzomib trials. Go to Setbacks may signal delay for Onyx.
To be clear, just because ImmunoGen’s fast track approval application was denied, doesn’t mean carfilzomib application will suffer the same fate. Onyx spokesperson, Lori Murray, responded to the new concerns this way: ““Today’s news about trastuzumab-DM1 does not change our plans,” Onyx spokeswoman Lori Murray said today in an e-mail. “We continue to believe there is a clear unmet medical need for patients with relapsed and refractory multiple myeloma.”
It is too early to panic. Let me see what I can find out.
Feel good, keep smiling and keep your fingers crossed- Pat