Drugmaker Bristol-Myers Squibb Co stated its combination of two medicine to deal with a type of skin cancer was accepted by the U.S. Food and Drug Administration.
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With a wholesale price of $141,000 to $256,000 for the combination, depending on length of treatment, even many insured patients may not be able to afford their portion of the tab, though Bristol-Myers and a few charities help many patients cover much of it.
The pairing of its older med Yervoy and new PD-1 cancer-fighter Opdivo won the FDA’s green light for patients with advanced melanoma and a particular genetic variation.
The announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. “[This] approval represents a step forward for the melanoma community, providing hope for patients with metastatic melanoma”.
“Today marks a milestone in the field of cancer immunotherapy”, says SITC President Howard L. Kaufman, MD, FACS (Rutgers Cancer Institute of New Jersey).
Safety and efficacy for the Opdivo-Yervoy combination were established in the Phase II, double-blind CheckMate-069 trial of 142 patients with previously untreated unresectable or metastatic melanoma who were randomized to receive Opdivo with Yervoy or Yervoy alone (OT 6/10/15 issue). The trial found that 58 percent of those who received both drugs had significant tumor shrinkage, compared with 44 percent in the group that took Opdivo alone and 19 percent for just Yervoy. In the study, similar PFS data were observed among patients with BRAF-positive melanoma (33 patients), at 8.5 versus 2.7 months in the combination (23 patients) and control (10 patients) arms, respectively. Almost 17% of patients treated with the combination had a complete response, while 43% had a partial response.
The combination also showed a 60% reduction in the risk of progression verus Yervoy monotherapy: median progression-free survival was 8.9 months versus 4.7 months, respectively.
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“This approval will establish the combination as a new standard of care for patients with metastatic melanoma”. The pharmaceutical giant said the treatment would be available immediately. SITC aims to one day make the word “cure” a reality for cancer patients everywhere.
