Keytruda has received two sBLA acceptances from FDA for the treatment of triple negative breast cancer:
The hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482, a novel investigational candidate, received Breakthrough Designation from FDA for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma with nonmetastatic RCC tumors less than three centimeters in size, unless immediate surgery is required.
FDA has cleared an investigational new drug application for CT-0508, an anti-human epidermal growth factor receptor 2-targeted chimeric antigen receptor macrophage.
BDTX-189 has received Fast Track Designation from FDA for the treatment of adult patients with solid tumors harboring an allosteric human epidermal growth factor receptor 2 mutation or an epidermal growth factor receptor or HER2 Exon 20 insertion mutation who have progressed following prior treatment and who have no satisfactory treatment options.
Tagrisso (osimertinib) has received Breakthrough Therapy Designation from FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent.
Piqray (alpelisib) received approval from the European Commission in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.
The FDA's Oncology Center of Excellence and Syapse presented data at the American Association of Clinical Research COVID-19 and Cancer meeting on an analysis of more than 212,000 health records of people living with cancer across two major health systems in the Midwestern United States.
An updated cervical cancer screening guideline from the American Cancer Society reflects the rapidly changing landscape of cervical cancer prevention in the United States, calling for less and more simplified screening.
Researchers at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and The Ohio State University Wexner Medical Center are conducting a clinical trial to determine if ibrutinib (Imbruvica) can help patients with cancer or other immunocompromised conditions recover from COVID-19.
Researchers at Fox Chase Cancer Center found that older patients who underwent chemoradiation therapy followed by removal of their esophagus due to cancer had toxicities and outcomes similar to younger patients.
