Bristol-Myers Squibb Grabs Record Fast Approval for Opdivo

Bristol-Myers Squibb (BMY) Grabs Record Fast Approval for Opdivo
March 5, 2015
By Alex Keown, BioSpace.com Breaking News Staff

PRINCETON, N.J.—The U.S. Food and Drug Administration (FDA) approved Bristol-Myers Squibb Company ’s Opdivo injection for treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, the company announced Thursday.

Opdivo (nivolumab) is an immuno-therapy drug delivered via injection that harnesses the patient’s own immune system to fight cancerous cells. Opdivo works by inhibiting the cellular pathway known as PD-1 protein on cells that blocks the body’s immune system from attacking cancerous cells. Opdivo is intended for patients who have previously been treated with platinum-based chemotherapy. Phase III clinical trials, dubbed CheckMate-017, showed higher survival rates for patients given Opdivo versus chemotherapy medication docetaxel, with a 42 percent reduction in the risk of death.

The trial measured the amount of time participants lived after starting treatment). On average, participants who received Opdivo lived 3.2 months longer than those participants who received docetaxel. The trial, which ended in January, studied 272 patients, of whom 135 received Opdivo and 137 received docetaxel.

Bristol-Myers Squibb is committed to patients with lung cancer, and we are pleased to offer Opdivo as the first immuno-oncology therapy for patients who have previously treated metastatic squamous NSCLC,” Lamberto Andreotti, CEO of Bristol-Myers Squibb, said in a press release. “Because lung cancer is one of the most commonly diagnosed cancers in the United States, with high mortality, there is a significant need for treatments that extend survival.”

NSCLC is one of the most common types of the disease and accounts for about 85 percent of cases. The squamous cell NSCLC, which Opdivo has shown success in treating during clinical trials, accounts for between 25 and 30 percent of all lung cancers. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed.

For Stage IV NSCLC, the five-year survival rate is 1 percent. Lung cancer is one of the leading causes of cancer deaths in the United States, killing 159,260 people in 2014. About 200,000 people are diagnosed with a form of lung cancer each year, according to the U.S. Centers for Disease Control and Prevention.

This is the second time Opdivo has been approved for use by the FDA. In December the federal agency granted accelerated approval to Opdivo for patients with advanced melanoma who no longer respond to other drugs, or cannot be treated via surgery.

The expanded use of Opdivo has been hailed by oncology professionals.

Suresh Ramalingam, director of medical oncology at the Winship Cancer Institute of Emory University said the approval of Opdivo introduces an “entirely new treatment modality that has demonstrated unprecedented results for the treatment of previously treated metastatic squamous NSCLC, with the potential to replace chemotherapy for these patients.”

The LUNGevity Foundation, a lung cancer nonprofit organization, applauded the FDA’s approval of Opdivo. Andrea Ferris, president of the foundation, touted the treatment options Opdivo provides for cancer patients, particularly those with NSCLC.

"Immunotherapy is transforming the lung cancer treatment paradigm, providing the most promising option yet in the second-line treatment for squamous cell lung cancer patients," Julie Brahmer, a LUNGevity scientific advisery board member and thoracic cancer director at Johns Hopkins Kimmel Cancer Center, said in a press release.

In February the FDA pulled the breakthrough drug designation for a planned hepatitis C medication, daclatasvir, produced by Bristol-Myers. The FDA requested additional data for daclatasvir in combination with other antiviral agents for the treatment of HCV after the withdrawal of asunaprevir as a combination medicine.



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