On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.
The Experiences of Women with Ovarian Cancer: From the First Symptoms Through Repeated Courses of Chemotherapy
Oral Medications Pose Challenges for Cancer Treatment But There Are Strategies for Improving Patient Adherence
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug designation to the agent for the treatment of soft tissue sarcomas.
"Guidelines offer all possible scenarios, while pathways comprise the details. The whole objective is to facilitate quality care in all aspects of the patient interaction, including their evaluation, prevention, treatment, education, supportive care, and end-of-life. Nevertheless, there’s still some mixing of definitions across the spectrum,” said Linda D. Bosserman, MD, FACP, FASCO.
FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
The FDA has granted priority review to Merck’s supplemental Biologics License Application for the anti-PD–1 agent pembrolizumab as monotherapy for certain patients with high-risk, non-muscle invasive bladder cancer who are ineligible for or have elected not to undergo cystectomy.
On August 16, 2019, the FDA approved fedratinib (Inrebic; Celgene/Impact Biomedicines), an oral kinase inhibitor, for adults with intermediate-2 or high-risk primary or secondary—post–polycythemia vera (PV) or post–essential thrombocythemia (ET)—myelofibrosis, a rare bone marrow disorder. The FDA granted fedratinib priority review and an orphan drug designation.
On September 17, 2019, the FDA approved a new indication for apalutamide (Erleada; Janssen Biotech) for the treatment of patients with metastatic castration-sensitive prostate cancer (CSPC). Apalutamide was initially approved in 2018 for the treatment of nonmetastatic castration-resistant prostate cancer. The FDA granted apalutamide priority review for the new indication.
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Results 21 - 30 of 180
Results 21 - 30 of 180