On April 21, 2014 Eli Lilly reported that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA (ramucirumab) as a single-agent treatment for patients with advanced or metastatic gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy (Press release Eli Lilly, APR 21, 2014, View Source [SID:1234500459]). With this approval, CYRAMZA becomes the first FDA-approved treatment for patients in this setting.
The CYRAMZA (ramucirumab injection 10 mg/mL solution) approval is based on results of REGARD, a multicenter, randomized, placebo-controlled, double-blind trial of patients with locally advanced or metastatic gastric cancer including GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy. It is the first Phase III trial to show improved overall survival and progression-free survival with a biologic agent in advanced gastric cancer after prior chemotherapy. Results demonstrated that CYRAMZA (8 mg/kg by infusion every two weeks) plus best supportive care (BSC), as compared to placebo plus BSC, increased the median overall survival of patients with advanced gastric cancer by 37 percent (median overall survival of 5.2 months [95% confidence interval (CI) 4.4, 5.7] vs. 3.8 months [95% CI 2.8, 4.7] for placebo, P=0.047, hazard ratio 0.78 [95% CI 0.60, 0.998]). Additionally, CYRAMZA significantly improved progression-free survival, demonstrating a 62 percent increase in median progression-free survival (2.1 months [95% CI 1.5, 2.7] vs. 1.3 months [95% CI 1.3, 1.4] for placebo, P < 0.001, hazard ratio 0.48 [95% CI 0.38, 0.62]). The labeling for CYRAMZA contains a Boxed Warning regarding increased risk of hemorrhage, including severe and sometimes fatal events. CYRAMZA should be discontinued in patients who experience severe bleeding. The most commonly reported adverse reactions (all grades) in REGARD, occurring in at least 5 percent of patients receiving CYRAMZA and at a rate at least 2 percent higher than those receiving placebo, were hypertension (16% vs. 8%), diarrhea (14% vs. 9%), headache (9% vs. 3%), and hyponatremia (6% vs. 2%). The most common serious adverse events with CYRAMZA were anemia (3.8%) and intestinal obstruction (2.1%). Red blood cell transfusions were given to 11% of CYRAMZA-treated patients vs. 8.7% of patients who received placebo. Across clinical trials of CYRAMZA administered as a single agent, clinically relevant adverse reactions (including Grade greater than or equal to 3) reported in CYRAMZA-treated patients included proteinuria, gastrointestinal perforation, and infusion-related reactions. In REGARD, according to laboratory assessment, 8% of CYRAMZA-treated patients developed proteinuria versus 3% of placebo-treated patients. Two patients discontinued CYRAMZA due to proteinuria. The rate of gastrointestinal perforation in the REGARD trial was 0.8% and the rate of infusion-related reactions was 0.4%. This is not a complete list of adverse reactions. FDA approval of CYRAMZA marks a pivotal regulatory milestone in Lilly's research and development program for the molecule, which it acquired when it purchased ImClone Systems in 2008. CYRAMZA has been granted Orphan Drug Designation by the FDA for this indication. Orphan drug status is given in the U.S. by the FDA's Office of Orphan Products Development (OOPD) to medicines that show promise for the treatment of rare diseases. Lilly expects to make CYRAMZA available in the coming weeks and is committed to offering patient assistance programs for eligible patients receiving CYRAMZA treatment.

On April 17, 2014 GlaxoSmithKline and Genmab reported that the U.S. Food and Drug Administration (FDA) has approved a Supplemental Biologic License Application (sBLA) for the use of Arzerra (ofatumumab), a CD20-directed monoclonal antibody, in combination with chlorambucil for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate (Press release Genmab, APR 17, 2014, View Source [SID:1234500440]).
The FDA approval of the first-line indication is based on results from a Phase III study (COMPLEMENT 1) which demonstrated statistically significant improvement in median progression-free survival (PFS) in patients who received the combination of ofatumumab and chlorambucil compared to patients who received chlorambucil alone.

On April 17, 2014 Kyowa Hakko Kirin reported that KHK and Amgen will terminate their licensing agreement in relation to mogamulizumab (Press release Kyowa Hakko Kirin, APR 17, 2014, View Source [SID:1234500438]).
Under the licensing agreement entered into on March 6, 2008, Amgen was granted exclusive rights to develop and commercialize Kyowa Hakko Kirin’s humanized monoclonal antibody mogamulizumab in all non-oncology indications worldwide, except in Japan, China, Korea and Taiwan.
After entering into the agreement, Amgen conducted clinical trials aimed at patients with asthma. Kyowa Hakko Kirin has completed a Phase 1 clinical trial in healthy Japanese adults, and will determine its future development policy after carefully considering the outcome of the Phase 1 results.

On April 17, 2014 Chugai Pharmaceutical announced that it will launch the anti-HER2 antibody-tubulin polymerization inhibitor conjugate Kadcyla Intravenous Infusion 100 mg and 160 mg for the indication of HER2-positive inoperable or recurrent breast cancer on April 18, 2014 (Press release Chugai, APR 17, 2014, View Source [SID:1234500434]). Kadcyla received a manufacturing and marketing approval on September 20, 2013 and was listed on the National Health Insurance (NHI) reimbursement price list on April 17, 2014.