Breast cancer, hepatitis C drugs get FDA approval

SILVER SPRING, Md. — The Food and Drug Administration this week has approved two new drugs, Gilead’s hepatitis C treatment Vosevi and Puma Biotechnology’s breast cancer drug Nerlynx. 

 

Nerlynx (neratinib) was approved for patients with early-stage, HER2-poitive breast cancer that is taken after initial treatment to lower the risk of the cancer returning. Roughly 15% of patients with breast cancer have tumors that are HER2-positive, and the National Cancer Institute estimates that 252,710 patients will be diagnosed with breast cancer this year. Nerlynx is indicated for patients who previously have been treated with a regimen that includes trastuzumab. 

 

“HER2-positive breast cancers are aggressive tumors and can spread to other parts of the body, making adjuvant therapy an important part of the treatment plan,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Now, these patients have an option after initial treatment that may help keep the cancer from coming baack.”

 

Gilead’s Vosevi, which received priority review and breakthrough therapy designations from the FDA, is the latest in its line of single-tablet drug regimens. It combines already approved drugs sofosbuvir and velpatasvir with the new drug voxilaprevir. It’s meant to treat patients who have previously been treated with direct-acting sofosbuvir or other drugs that inhibit a protein called NS5A. 

 

“Direct-acting antiviral drugs prevent the virus from multiplying and often cure HCV,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Vosevi provides a treatment option for some patients who were not successfully treated with other HCV drugs in the past.”

 

Vosevi is the fourth hepatitis C treatment since 2015 from Gilead, including three single-tablet regimens. The drug comes with a boxed warning about the risk of hepatitis B reinfection among coinfected patients. 

 

“The evolution of Gilead’s portfolio of HCV single-tablet regimens has been driven by our commitment to address previously unmet needs and put the possibility of cure within reach for as many HCV patient populations as possible,” Gilead president and CEO John F. Milligan said. “The approval of Vosevi completes our portfolio by fulfilling the unmet need for an effective regimen for patients who could not be cured, despite prior treatment with certain DAA regimens.”