As a veteran of the FDA Oncologic Drugs Advisory Committee, Maha Hussain took part in the group's past discussions on treatment options for men with non-metastatic castration-resistant prostate cancer.
The endpoint of metastasis-free survival is unlikely to be used in settings beyond non-metastatic castration-resistant prostate cancer, said Julia Beaver, director of Division of Oncology Products 1 at the FDA Center for Drug Evaluation and Research.
It's official, FDA is recognizing a new endpoint that seems especially well suited for prostate cancer: metastasis-free survival, or MFS for short.
The two FDA pilot programs—Real-Time Oncology Review and Assessment Aid sped up the processing of Novartis's supplemental new drug applications for Kisqali (ribociclib), said Samit Hirawat, executive vice president and head of Global Oncology at Novartis.
FDA is revamping the gearing in the machinery of approval of cancer drugs, making it possible to initiate regulatory review immediately after the clinical trials datasets are locked.
Genentech, a member of the Roche Group, said FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial treatment for people with advanced or metastatic hepatocellular.
Mersana Therapeutics Inc. announced that FDA has placed the phase I study of XMT-1522 on partial clinical hold.
Bristol-Myers Squibb Co. and Gritstone Oncology announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone's personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-basedvector (prime) and a self-replicating RNA-based vector (boost), in combination with Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
FDA approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia who have a specific genetic mutation. This first drug in its class (IDH1 inhibitors) is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.
Genentech said the phase III IMpower132 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of Tecentriq (atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death compared to chemotherapy alone in the initial treatment of advanced non-squamous non-small cell lung cancer.
