Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma.
The U.S. Food and Drug Administration (FDA) gave the promising autoimmunity drug Opdivo a Breakthrough Therapy Designation for the treatment of the most common form of kidney cancer according to a statement Thursday by the drug’s maker Bristol-Myers Squibb. The designation, which was created in 2012, calls for expedited reviews of medications that could treat life-threatening conditions. The announcement comes after a Phase 3 study of patients with advanced renal cell carcinoma (RCC) showed a significant increase in survival compared to the current treatment standard, Afinitor. The study, entitled CheckMate -025, was halted prematurely in July after independent monitors concluded that it had exceeded the requirements for success. Opdivo became the first medication that positively affected survival rates for RCC, a disease that has limited treatment options.
Bristol-Myer’s senior vice president and head of development and oncology Michael Giordano said about the study’s results, “The Breakthrough Therapy Designation in advanced renal cell carcinoma is a clear signal of the need for additional treatment approaches for RCC and reflects part of our broad commitment to Immuno-Oncology research that may address many types of advanced cancers.” Opdivo, and its generic form nivolumab works to prevent PD-1 molecules from interfering with the immune system’s ability to attack tumors. As one of the deadliest forms of cancer, RCC kills about 100,000 people per year, with the five year survival rate of patients diagnosed with advanced RCC having a five-year survival rate of 12.1 percent. Despite the drug’s darling status, the Opdivo did produce some notable side effects, including severe lung disease, with five fatal cases among the 691 patients studied among the three trials. Also, 21 percent of trials 1 and 3 patients experienced diarrhea or colitis during the trial. The tests also revealed an increase in abnormal liver tests as well as several other renal-related abnormalities.
Opdivo was first approved in Japan in July 2014 for the treatment of melanoma and nivolumab was approved by the European Commission this past July for the treatment of lung cancer. The FDA also approved Opdivo for the treatment of melanoma in December and lung cancer in March. In addition to being granted breakthrough designation prior to its two FDA approvals, it has also been given the status for the treatment of Hodgkin lymphoma. While there are some side-effect concerns, the breakthrough status likely means that FDA approval is imminent and should be expected sooner rather than later, although a specific timeframe has yet to be announced. Opdivo’s recent success follows the 2011 FDA approval of another major immunotherapy cancer drug from Bristol, Yervoy, to treat metastatic melanoma. Yervoy earned the company over $1.31 billion in 2014.
Bidness Etc – Martin Blanc
MarketWatch – Bristol-Myers Squibb
PharmaTimes – Selina McKee
Wall Street Journal – Tess Stynes