On February 4, 2015 Roche reported positive results from the Phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to MabThera/Rituxan (rituximab) treatment (Press release Hoffmann-La Roche , FEB 4, 2015, View Source [SID:1234501453]). At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival, PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected adverse events with Gazyva.

“GADOLIN is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease.”

Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the U.S. Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.

On February 3, 2015 Janssen Research & Development reported that the U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for YONDELIS (trabectedin) to treat patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline (Press release Johnson & Johnson, FEB 3, 2015, View Source [SID:1234501451]). Janssen submitted the NDA to the FDA on November 24, 2014.

Priority Review is a designation for a drug that treats a serious condition and may offer major advances in treatment when compared to existing options. A priority review designation means the FDA’s goal is to take action, following the two month period for the validation and acceptance of the NDA, within six months as compared to 10 months under standard review.

The filing is based on the Phase 3 randomized, open-label study ET743-SAR-3007. This trial is evaluating the safety and efficacy of trabectedin versus dacarbazine for the treatment of patients with advanced liposarcoma and leiomyosarcoma, the most common types of STS in adults, in more than 500 patients previously treated with an anthracycline and ifosfamide, or an anthracycline followed by one additional line of chemotherapy. Results of the study will be presented at a future date.

“We are excited the FDA has granted Priority Review for YONDELIS, as it is an important step forward in making this therapy available to physicians and those living with this aggressive disease,” said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen.

On February 2, 2015 Roche reported that it has received a second Breakthrough Therapy Designation from the United States Food and Drug Administration (FDA) for its investigational cancer immunotherapy MPDL3280A (anti-PDL1) (Press release Hoffmann-La Roche , FEB 1, 2015, View Source [SID:1234501442]). The designation was granted for the treatment of people with PD-L1-positive (Programmed Death-Ligand 1) non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumour).

“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,’’ said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are committed to personalised healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines. ”

This breakthrough therapy designation is based on early results of MPDL3280A in people whose NSCLC was characterised as PD-L1-positive by an investigational test being developed by Roche. All studies of MPDL3280A are prospectively evaluating PD-L1 expression. Some studies will evaluate the medicine regardless of a tumor’s PD-L1 status; other studies are evaluating the medicine only in people whose tumors are characterized as PD-L1 positive.

Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious diseases and to help ensure patients have access to them through FDA approval as soon as possible. The FDA granted the first Breakthrough Therapy Designation for MPDL3280A in metastatic bladder cancer in 2014. Ongoing pivotal studies of MPDL3280A include lung and bladder cancer, and we plan to initiate Phase III studies in additional tumor types this year.