Novartis said the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resection.
Eisai Co. Ltd. and Merck said FDA granted Breakthrough Therapy designation for Lenvima (lenvatinib), the orally available kinase inhibitor discovered by Eisai, in combination with Merck's anti-PD-1 therapy Keytruda (pembrolizumab) for the potential treatment of patients with advanced and/or metastatic non-microsatellite instability high/proficient mismatch repair endometrial carcinoma who have progressed following at least one prior systemic therapy.
Trazimera, a biosimilar to Herceptin (trastuzumab), for the treatment of human epidermal growth factor overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, received European Commission approval.
FDA approved Magtrace and Sentimag Magnetic Localization System (Sentimag System), a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. It uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal.
Celyad said FDA has accepted the company's Investigational New Drug application for CYAD-101, the first non-gene edited allogeneic clinical program. FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.
The China National Drug Administration approved Merck's Keytruda for the treatment of adult patients with unresectable or metastatic melanoma following failure of one prior line of therapy. This is the first approval of an anti-PD-1 therapy for advanced melanoma in China.
Bristol-Myers Squibb Co. and Tsinghua University have entered into a collaboration to discover therapeutic agents against novel targets for autoimmune diseases and cancers.
Genentech, a member of the Roche Group, said FDA has granted Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as an initial treatment for people with advanced or metastatic hepatocellular.
Mersana Therapeutics Inc. announced that FDA has placed the phase I study of XMT-1522 on partial clinical hold.
Bristol-Myers Squibb Co. and Gritstone Oncology announced that the companies have entered into a clinical trial collaboration to evaluate the safety and tolerability of Gritstone's personalized neoantigen immunotherapy, GRANITE-001, which comprises sequential delivery of neoantigens to patients within an adenovirus-basedvector (prime) and a self-replicating RNA-based vector (boost), in combination with Opdivo (nivolumab), and Opdivo plus Yervoy (ipilimumab), in patients with advanced solid tumors.
