The Roche-Syapse collaboration to develop analytics programs may enable health systems to measure the impact of precision therapies, said Damon Hostin, CEO of the Precision Medicine Alliance.
Syapse and Roche are working on building software that would allow health systems to incorporate real-world evidence into Syapse's platform in an effort to develop true clinical decision support for precision therapies.
Roche has teamed up with the precision medicine company Syapse to develop software for measuring health outcomes and economic impact of precision medicine.
FDA has approved Genentech's Perjeta (pertuzumab), in combination with Herceptin (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence.
FDA approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with advanced renal cell carcinoma.
FDA approved a supplemental New Drug Application to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphiachromosome-positive chronic myelogenous leukemia.
Amgen said FDA has approved the supplemental Biologics License Application for Xgeva (denosumab) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
Kisqali (ribociclib) received FDA Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in combination with tamoxifen or an aromatase inhibitor.
FDA has accepted for filing a supplemental Biologics License Application for Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA granted Priority Review for the application, and the Prescription Drug User Fee Act target action date is May 1, 2018.
FDA has granted Breakthrough Therapy Designation for Avelumab in combination with Inlyta (axitinib) for treatment-naïve patients with advanced renal cell carcinoma.
