On February 19, 2015 Kite Pharma reported that it has entered into a lease agreement for a commercial manufacturing facility in El Segundo, California, which is adjacent to Los Angeles International Airport (Filing 8-K , Kite Pharma, FEB 19, 2015, View Source [SID:1234501710]). Kite also recently secured a lease for a clinical manufacturing facility in Santa Monica, California. The two facilities will not only support the planned clinical trials of Kite’s product candidates, but also will prepare Kite for the commercial launch and supply of its lead product candidate, KTE-C19, anticipated in 2017.

“We are committed to the rapid advancement of KTE-C19, which has the potential to address the significant, unmet needs of patients with aggressive, refractory B cell lymphomas and leukemias,” said Arie Belldegrun, M.D., FACS, Kite Pharma’s President and Chief Executive Officer. “We are initiating pivotal studies for KTE-C19 in multiple indications and believe our new facilities will help ensure the timely completion of these studies as well as our commercial launch. We also expect the facilities to support clinical trials and potential commercialization of our other eACT based product candidates, including both chimeric antigen receptor (CAR) and T cell receptor (TCR) based product candidates.”

The Santa Monica facility has approximately 18,000 square feet and will provide space for clinical manufacturing, research and development, and offices upon completion. In addition, Kite plans to continue to utilize its contract manufacturer to support clinical trials of eACT based product candidates.

The El Segundo facility has approximately 44,500 square feet, and, under the lease agreement, Kite has an expansion option for an additional 17,000 square feet until July 1, 2017. Kite was represented in the negotiation of the lease by Andrew Riley and Jeff Pion of CBRE. Kite anticipates the El Segundo facility will be operational to support the planned commercial launch of KTE-C19 in 2017.

Commenting on the new leases, Cynthia Butitta, Kite’s Chief Operating Officer and Chief Financial Officer, said, “Securing these manufacturing facilities fits strategically with our expansion and is an exciting and necessary step as we advance multiple clinical trials and prepare for commercialization of our product candidates.”

On February 19, 2015 Roche reported that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for the company’s New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma (Press release Hoffmann-La Roche , FEB 18, 2015, View Source [SID:1234501708]). The FDA will make a decision on approval by August 11, 2015.

“We are pleased the FDA has accepted our application for cobimetinib in combination with Zelboraf and granted it priority review status,” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development. “We look forward to working with the FDA to bring this new treatment option to people with BRAF mutation-positive advanced melanoma as soon as possible.”

A priority review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The NDA is based on results of the coBRIM Phase III study, which showed the MEK inhibitor cobimetinib plus Zelboraf reduced the risk of disease worsening or death by half in people who received the combination (hazard ratio [HR]=0.51, 95 percent confidence interval [CI] 0.39-0.68; p<0.0001), with a median PFS of 9.9 months for cobimetinib plus Zelboraf compared to 6.2 months with Zelboraf alone. The safety profile was consistent with a previous study of the combination. The most common Grade 3 or higher adverse events in the combination arm included liver lab value abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and diarrhea. The most common adverse events seen in the combination arm included diarrhea, nausea, rash, photosensitivity and lab value abnormalities.