“Bristol-Myers Squibb Co on Thursday said it has decided not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.
“Shares of Bristol, which closed at $55.49 on the New York Stock Exchange, were down 6.2 percent at $52.08 after hours.
“The pharmaceutical company cited ‘a review of data available at this time’ for the decision to hold off on filing for Food and Drug Administration approval of the combination of its cancer drugs Opdivo and Yervoy.”
Last year, the U.S. Food and Drug Administration (FDA) approved two anti-PD-1 checkpoint inhibitors, a type of immunotherapy, for treatment of non-small cell lung cancer (NSCLC) in patients whose cancer has progressed after first-line treatment with chemotherapy. Now, the manufacturers of both drugs, pembrolizumab (made by Merck) and nivolumab (made by Bristol-Myers Squibb; BMS) are intent on expanding the indications for use of their drugs. To this end, they have conducted clinical trials testing each as a first-line treatment (i.e., in previously untreated patients), comparing them to standard chemotherapy. Continue reading…
“Patients with advanced unresectable melanoma can safely receive combination therapy with full doses of talimogene laherparepvec and pembrolizumab, according to study results presented at HemOnc TodayMelanoma and Cutaneous Malignancies.
“In previous studies, talimogene laherparepvec (Imlygic, Amgen) — a herpes simplex virus-1-based oncolytic immunotherapy — significantly improved durable response rate in patients with advanced melanoma. Also, pembrolizumab (Keytruda, Merck) — an anti–PD-1 antibody — showed superiority over ipilimumab (Yervoy, Bristol Meyers Squibb) in patients with stage III or IV melanoma.
“Both drugs appeared tolerable and demonstrated nonoverlapping adverse event profiles…”
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“Bristol-Myers Squibb Co. has sprinted to an early lead in the race to sell a new class of cancer treatment by bucking the trend toward precision medicine.
“For years, drug companies tried to sell medicines to as many patients as possible. More recently, under pressure from health insurers aiming to improve the odds a costly drug will work, many pharmaceutical companies have been pairing their new therapies with diagnostic tests…”
“The review period for frontline nivolumab (Opdivo), in patients who have advanced melanoma, recently received an extension of 3 months by the FDA, in order to allow ample time for review of the additional data submitted by Bristol-Myers Squibb (BMS). The updated action date for the new indication is November 27, 2015.
“Nivolumab initially received a priority review designation for the new indication on April 30, 2015, based on the phase III CheckMate-066 trial that explored nivolumab in untreated patients with BRAF wild-type advanced melanoma. The new data hope to support an approval that is irrespective of BRAF status, BMS indicated.
“ ‘The CheckMate-066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomized phase III trial,’ Michael Giordano, MD, senior vice president, Head of Development, Oncology, BMS, said when the FDA initially accepted the application. ‘We look forward to continuing to work with the FDA to ensure cancer patients are provided the latest clinical advances that have the potential for improved responses and long-term survival.’ “