FDA Approves Gastric Cancer Treatment

The FDA today approved a drug previously granted Orphan Drug Designation for the treatment of gastric cancer after prior chemotherapy.

Eli Lilly and Company’s drug ramucirumab (Cyramza) in combination with chemotherapy drug paclitaxel acts as a treatment for patients with advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after previously receiving chemotherapy.

"This FDA approval of Cyramza represents another milestone for people battling this devastating and difficult-to-treat disease," Richard Gaynor, MD, senior vice president of product development and medical affairs for Lilly Oncology said in a press release. "Lilly is pleased to continue delivering on its commitment to provide new treatment options to people living with cancer and those who care for them."

In a multinational, randomized, double-blinded, placebo-controlled phase 3 trial, researchers evaluated ramucirumab plus paclitaxel compared with placebo plus paclitaxel in patients with locally advanced or metastatic gastric or GEJ adenocarcinoma, whose cancer progressed after treatment with fluoropyrimidine- and platinum-containing chemotherapy.

The study randomized 665 patients throughout 27 countries in North America, South America, Europe, Australia, and Asia. The trial was the first phase 3 study to demonstrate the survival benefit with a biologic used in combination with chemotherapy in this setting.

Ramucirumab with paclitaxel was found to significantly extend median overall survival compared with placebo and paclitaxel (9.6 months [95% confidence interval (CI): 8.5, 10.8] vs. 7.4 months [95% CI: 6.3, 8.4], respectively. Additionally, ramucirumab plus paclitaxel significantly delayed disease progression, with a progression-free survival of 4.4 months for ramucirumab plus paclitaxel (95% CI: 4.2, 5.3), compared with 2.9 months for placebo plus paclitaxel (95% CI: 2.8, 3.0).

Additionally, more patients responded to ramucirumab combined with paclitaxel than with paclitaxel alone (28% [95% CI: 23, 33] for ramucirumab plus paclitaxel vs. 16% [95% CI: 13, 20] for placebo plus paclitaxel; P < 0.001).

The percentage of deaths was 78% (256 patients) and 78% (260 patients) at the time of analysis in the ramucirumab plus paclitaxel and placebo plus paclitaxel cohorts, respectively. The progression-free survival number of events was 279 (85%) and 296 (88%) for the ramucirumab plus paclitaxel and the placebo plus paclitaxel treatment arms, respectively.

The most common adverse events in patients treated with ramucirumab plus paclitaxel at a rate of ≥30% and ≥2% higher than placebo plus paclitaxel were fatigue (57% vs. 44%), neutropenia (54% vs. 31%), diarrhea (32% vs. 23%), and epistaxis (31% vs. 7%).