FDA has approved ibrutinib (Imbruvica) for adult patients with chronic graft versus host disease after failure of one or more lines of systemic therapy, making it the first FDA-approved therapy for the treatment of cGVHD.
Amgen and Allergan plc. said they have submitted a Biologics License Application to FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab).
Kite Pharma Inc. said it has submitted a Marketing Authorization Application to the European Medicines Agency for axicabtagene ciloleucel as a treatment for patients with relapsed/refractory diffuse large B-cell lymphoma , transformed follicular lymphoma, and primary mediastinal B-cell lymphoma who are ineligible for autologous stem cell transplant.
Bristol-Myers Squibb Co. and IFM Therapeutics signed a definitive agreement under which BMS will acquire all of the outstanding capital stock of IFM Therapeutics, a venture-backed biotech company focused on developing therapies that modulate novel targets in the innate immune system to treat cancer, autoimmunity and inflammatory disorders.
Bristol-Myers Squibb Co. and Clovis Oncology Inc. formed a clinical collaboration to evaluate the combination of BMS's Opdivo and Clovis Oncology's poly (ADP-ribose) polymerase inhibitor Rubraca in pivotal phase III clinical trials in:
Loxo Oncology Inc. said the company has entered into an agreement to purchase the Bruton's tyrosine kinase inhibitor program from RedxPharma Plc. The lead candidate from this program is expected to enter clinical development in 2018. Under the terms of the agreement, Loxo Oncology has made a $40 million payment to Redx Pharma Plc for the full acquisition of the BTK discovery program, including lead candidate LOXO-305 (formerly RXC005). Loxo Oncology is not subject to milestone or royalty obligations.
Indivumed will partner with MedStar Health to help individualize anti-cancer medical therapies through biospecimen collection, preservation and analysis.
FDA approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.
Merck KGaA, which operates its biopharmaceutical business as EMD Serono in the U.S. and Canada, and Pfizer Inc. said the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended the approval of avelumab (Bavencio) as a monotherapy for the treatment of adult patients with metastatic Merkel cell carcinoma.
Bristol-Myers Squibb Co. said FDA has expanded the indication for Yervoy (ipilimumab) injection for intravenous use to now include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older.
