Medivation (MDVN +2% premarket) and Astellas Pharma (ALPMF) have filed a request with the FDA to widen the use of their Xtandi product to treat men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.
Xtandi is already approved for the treatment of patients with mCRPC who have received Docetaxel chemotherapy.
The companies intend to file a similar request in the EU later this year. (PR)
Aveo Oncology (AVEO) and Japan's Astellas Pharma (ALPMF) are ending their agreement to develop Aveo's lead drug Tivozanib and they will halt a Phase II study testing its use in colon cancer.
The move comes after Aveo said in January that it would end a similar-stage trial of Tivozanib as a treatment for breast cancer because of poor enrollments. In July, the drug was rejected as a treatment for kidney cancer because of inconsistent study results.
Aveo Oncology (AVEO) and Japanese partner Astellas Pharma (ALPMF) plan to end a Phase II study of the Tivozanib drug for treating breast cancer after not being able to enroll enough patients in the trial.
The latest blow to Aveo comes after the FDA rejected Tivozanib as a treatment for kidney cancer in June, due to inconsistent study results. (PR)
Aveo Pharma (AVEO -15.1%) says its lead experimental drug tivozanib was unlikely to succeed in a mid-stage colon cancer study that was testing if the drug was superior to an approved treatment.
Partner Astellas (ALPMF, ALPMY) was testing the drug in combination with standard chemotherapy against cancer drug bevacizumab with standard chemotherapy, for use in previously untreated patients with advanced colorectal cancer.
Aveo has seen a string of failures associated with the drug; the FDA denied approval for the drug's use in renal cell carcinoma in June, citing inconsistent patient survival data.
After observing benefits in OS and radiographic PFS (co-primary endpoints), the IDMC for Medivation (MDVN +3.7%) and Astellas Pharma's (ALPMF +0.9%) Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends "the study be stopped and patients treated with placebo be offered enzalutamide."
Enzalutamide reduced the risk of death by 30% (Hazard Ratio .70), and patients saw an 81% reduction in risk of radiographic progression or death (Hazard Ratio 0.19).
Here's Dr. Tomasz Beer, professor of medicine and deputy director of the Knight Cancer Institute: "To my knowledge, the benefits in overall survival and radiographic progression-free survival reported in today's PREVAIL trial results are unprecedented in this patient population." (PR)
Medivation (MDV) and Astellas (ALPMF.PK) enroll the first patient in a Phase II trial for enzalutamide, a treatment for triple-negative breast cancer, for which "there are no approved targeted therapies." The trial will recruit approximately 80 patients, who will take enzalutamide orally once a day. (PR)
Cytokinetics (CYTK +9.8%) grants Astellas (ALPMF.PK) an exclusive license to co-develop and commercialize Cytokinetics' CK-2127107 treatment for muscle weakness, which is in Phase I trials. Cytokinetics will receive $16M up front and is eligible to receive over $24M in reimbursements during the first two years. Astellas could also pay $450M in R&D and sales milestones and royalties, as well as make other milestone payments. (8-K)
Health Canada approves Medivation (MDVN) and Astellas' (ALPMY.PK) XTANDI (enzalutamide) for the treatment of metastatic castration-resistant prostate cancer. (Previous: XTANDI submitted to Japanese regulators; XTANDI sales rise)
Amgen (AMGN -0.6%) forms a JV with Japan's Astellas Pharma (ALPMF.PK) to develop and sell five new drugs in the latter's home country, with the hope being to launch the first medicine in 2016. The JV should help Amgen partly fill what it has described as "a noticeable gap" - its absence from China and Japan. (PR)
Medivation (MDVN +0.6%) and Astellas Pharma (ALPMF.PK) say the Committee for Medicinal Products for Human Use (CHMP) has recommended approval for the oral androgen receptor inhibitor XTANDI (approved in the U.S.) for adult men with progressed metastatic castration-resistant prostate cancer. Other CHMP news: Pfizer's (PFE -1.1%) arthritis pill Xeljanz is rejected (appeal to come), Roche (RHHBY.OB +0.2%) and Curis' (CRIS +4.5%) Erivedge for basal cell carcinoma gets a recommendation, and Vivus' (VVUS +3.7%) ED drug Spedra gets a positive review. (See also: AVNR and CELG get thumbs up from EU regulators)
The combination of Tarceva and Nexavar tablets to treat liver cancer didn't improve survival rates compared with Nexavar on its own in a Phase III trial. Nexavar is jointly produced by Bayer and Onyx (ONXX -0.45%), while Tarceva, which is already used in lung cancer, is sold by Astellas Pharma and Roche unit Genentech.