FLASCO
- FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive non-small cell lung cancer September 22, 2022On September 21, 2022, the Food and Drug Administration granted regular approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a rearranged during transfection (RET) gene fusion, as detected by an FDA-approved test. Today, FDA also approved the Oncomine Dx Target (ODxT)...
- FDA approves selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors September 22, 2022On September 21, 2022, the Food and Drug Administration granted accelerated approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult patients with locally advanced or metastatic solid tumors with a rearranged during transfection (RET) gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Efficacy...
- September is Blood Cancer (Disparity) Awareness month September 14, 2022There is disparity in hematologic malignancies in incidence, outcome, survivorship, and clinical trial access. However, there is progress in health equity in hematologic malignancies. Attached are few representative publications. The problem of disparity in hematologic malignancies. “Are Pivotal Clinical Trials for Drugs Approved for Leukemias and Multiple Myeloma Representative of the Population at Risk?” published in JCO...
- FDA approves pemigatinib for relapsed or refractory myeloid/lymphoid neoplasms with FGFR1 rearrangement August 30, 2022On August 26, 2022, the Food and Drug Administration approved pemigatinib (Pemazyre, Incyte Corporation) for adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangement. Efficacy was evaluated in FIGHT-203 (NCT03011372), a multicenter open-label, single-arm trial that included 28 patients with relapsed or refractory MLNs with FGFR1 rearrangement. Eligible...
- FDA Clinical Trial Diversity Guidance August 30, 2022Per the ASCO Daily Post, the U.S. Food and Drug Administration has issued a draft guidance “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry (fda.gov)” at https://www.regulations.gov. for sponsors developing medical products to include a diversity plan, focusing on racial and ethnic diversity, in...
- FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for HER2-mutant non-small cell lung cancer August 12, 2022On August 11, 2022, the Food and Drug Administration granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a...
- FDA approves capmatinib for metastatic non-small cell lung cancer August 11, 2022On August 10, 2022, the Food and Drug Administration granted regular approval to capmatinib (Tabrecta, Novartis Pharmaceuticals Corp.) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test. Capmatinib was previously granted accelerated approval for the...
- Increasing Racial and Ethnic Diversity in Cancer Clinical Trials: An American Society of Clinical Oncology and Association of Community Cancer Centers Joint Research Statement | Journal of Clinical Oncology August 9, 2022The American Society of Clinical Oncology (ASCO) and the Association of Community Cancer Centers (ACCC) released two new resources to help research sites increase racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials with publication of an article in The Journal of Clinical Oncology that detailed six overarching recommendations for improving EDI in cancer...
- FDA approves darolutamide tablets for metastatic hormone-sensitive prostate cancer August 8, 2022On August 5, 2022, the Food and Drug Administration approved darolutamide (Nubeqa, Bayer HealthCare Pharmaceuticals Inc.) tablets in combination with docetaxel for adult patients with metastatic hormone-sensitive prostate cancer (mHSPC). Efficacy was based on ARASENS (NCT02799602), a randomized, multicenter, double-blind, placebo-controlled clinical trial in 1306 patients with mHSPC. Patients were randomized to receive either darolutamide...
- FDA approves crizotinib for ALK-positive inflammatory myofibroblastic tumor July 14, 2022On July 14, 2022, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for adult and pediatric patients 1 year of age and older with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). The safety and efficacy of crizotinib were evaluated in two multicenter, single-arm, open-label trials that included 14...