FDA Update – October 2014

October 2014, Vol 5 , No 8 - FDA Approvals, News & Updates


FDA Approves New Combination Therapy, Akynzeo, for the Prevention of Nausea and Vomiting Associated with Chemotherapy
The FDA approved a new fixed-dose combination of netupitant and palonosetron (Akynzeo; Eisai/Helsinn Healthcare) for the treatment of patients with cancer who experience chemotherapy-induced nausea and vomiting (CINV).

This new oral capsule combines the oral 5-HT3 receptor antagonist palonosetron, which is already approved by the FDA for the prevention of CINV, and the new drug netupitant, a selective antagonist of human substance P/neurokinin 1/(NK1). Activation of the NK1 family has been associated with delayed emesis.

The FDA approved the new combination for the prevention of CINV at the acute phase (ie, during the first 24 hours) after the start of chemotherapy administration. The combination of netupitant plus palonosetron has been shown to prevent nausea and vomiting during the acute and the delayed phases after the start of chemotherapy.

“Supportive care products, such as Akynzeo, help ease the nausea and vomiting patients may experience as a side effect of cancer chemotherapy,” said Julie Beitz, MD, Director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research.

The FDA established the efficacy of the new combination based on 2 clinical trials that included a total of 1720 patients with cancer who were receiving chemotherapy. The patients were randomized to the combination of netupitant plus palonosetron or to palonosetron alone.

The efficacy end points in the first trial were complete response (CR)—defined as no emetic episodes (ie, no vomiting or nausea events) and no rescue medication use—rates during the acute (0-24 hours) phase and the delayed (25-120) phase, as well as the CR rates within the overall phase (120 hours) after the start of the chemotherapy administration.

The results of the first trial showed CR rates of 98.5%, 90.4%, and 89.6% during the acute, delayed, and overall phases, respectively, after the start of chemotherapy. By comparison, the CR rates in patients receiving oral palonosetron alone were significantly lower, at 89.7%, 80.1%, and 76.5%, respectively.

The primary efficacy end point of the second trial was the CR rates in the delayed phase. The CR rates were significantly higher, 76.9%, with the combination therapy agent compared with 69.5% with palonosetron alone (P = .001).

Common side effects with the combination drug reported in the clinical trials included asthenia, dyspepsia, constipation, erythema, fatigue, and headache.

(October 10, 2014)




FDA Grants Priority Review for Palbociclib, a Novel Breast Cancer Drug
The FDA has granted a priority review status to the CDK 4/6 inhibitor palbociclib (Pfizer) for the treatment of women with advanced or metastatic estrogen receptor–positive, HER2-positive breast cancer. Palbociclib is already designated as a breakthrough therapy by the FDA. The PDUFA date for palbociclib is April 13, 2015, but the new priority review status may push that date forward by as much as 4 months.

“If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the United States who are living with metastatic breast cancer,” noted Garry Nicholson, President, Pfizer Oncology. “We look forward to continuing to work closely with the FDA through the review process.”

(October 13, 2014)