FDA has requesting that Allergan, the manufacturer of a specific type of textured implant, recall specific models of its textured breast implants from the U.S. market due to the risk of breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
Pembrolizumab (Keytruda) has become the first medicine to have additional indications registered on the Australian Register of Therapeutic Goods via the provisional approval pathway.
FDA approved FoundationOneCDx to be used as a companion diagnostic for Lynparza (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer.
FDA has granted an accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, including at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
FDA has approved Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma; metastatic renal cell carcinoma; and persistent, recurrent, or metastatic cervical cancer.
The European Commission has granted conditional marketing authorization for Libtayo for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation
FDA has approved the use of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
The European Commission has granted a marketing authorisation for Trecondi (treosulfan), as part of conditioning treatment prior to alloHSCT in adult patients with malignant and non-malignant diseases and in paediatric patients with malignant diseases.
FDA has allowed Athenex Inc.'s Investigational New Drug application for the clinical investigation of PT01 (Pegtomarginase) for the treatment of patients with advanced malignancies.
Intensity Therapeutics Inc. has entered into an agreement with Merck to evaluate the combination of Intensity's lead product candidate INT230-6 and Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, in patients with advanced solid malignancies including pancreatic, bile duct, squamous cell, and non-MSI high colon cancers.
