Notizie Newsletter
SITC Introduces Guidelines for Anti–PD-1 Therapy in HNSCC
October 30, 2019 - Based on strong findings for efficacy and safety, as well as FDA approvals, the Society for Immunotherapy of Cancer (SITC) has issued the first guidelines for the use of immunotherapy agents in patients with recurrent or metastatic (RM) head and neck squamous ...Leggi tutto
Stephen Hahn, MD, to Be Nominated FDA Commissioner
November 1, 2019 - In a press release issued by the White House today, President Donald J. Trump announced his intention to nominate Stephen Hahn, MD, FASTRO, to be the Commissioner of Food and Drugs at the Department of Health and Human Services. Dr. Hahn has been Chief ...Leggi tutto
Avelumab monotherapy as first-line or second-line treatment in patients with metastatic renal cell carcinoma: phase Ib results from the JAVELIN Solid Tumor trial
Antibodies targeting programmed death-1 (PD-1) or programmed death-ligand 1 (PD-L1) have shown clinical activity in the treatment of metastatic renal cell carcinoma (mRCC). This phase Ib cohort of the JAVELIN Solid Tumor trial assessed the efficacy and safety of avelumab ...Leggi tutto
FDA Will Split Avapritinib GIST NDA Into Separate Submissions
October 28, 2019 - The FDA has informed Blueprint Medicines that it intends to split the proposed indications for its agent avapritinib into two separate new drug applications (NDAs) for patients with gastrointestinal stromal tumor (GIST): one for patients with PDGFRA exon ...Leggi tutto
Regulatory update – EMA encourages companies to submit type I variations for 2019 by end of November 2019
October 29, 2019 - The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2019 no later than Friday 29 November 2019. This will enable EMA to acknowledge the validity of the submissions before the Agency's ...Leggi tutto