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Web Exclusives published on December 16, 2019 in In the News, Pediatric Cancer
On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology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.
Web Exclusives published on December 12, 2019 in Ovarian Cancer
The ovarian cancer patients’ internal dialogue may delay a cancer diagnosis and can also overestimate the capability of chemotherapy.
Web Exclusives published on December 12, 2019 in Ovarian Cancer
BRCA wild-type tumors are more common in women with ovarian cancer and may need higher doses of the tumor-targeting PARP inhibitor.
Web Exclusives published on December 12, 2019 in Ovarian Cancer
The rise in the number of cancer drugs taken orally has placed a renewed focus on the importance—and challenges—of patient adherence to self-administered oral medications.
Web Exclusives published on December 12, 2019 in Ovarian Cancer
While Medicare Part D enrollees may see their out-of-pocket expenses, deductibles, and premiums increase in 2020, protections of the drugs used in cancer treatment will remain in place.
Web Exclusives published on December 11, 2019 in FDA Updates, In the News, Sarcoma
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.
Web Exclusives published on December 9, 2019 in Clinical Pathways
"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.
Web Exclusives published on December 3, 2019 in Bladder Cancer, FDA Updates, Immunotherapy
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.
Web Exclusives published on December 2, 2019 in FDA Updates
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.
Web Exclusives published on December 2, 2019 in FDA Updates
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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