FDA has approved Genentech's Kadcyla (ado-trastuzumab emtansine) for adjuvant treatment of people with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment.
FDA has granted Breakthrough Device designation to Natera Inc.'s Signatera test for use in the post-surgical detection and quantification of circulating tumor DNA in the blood of patients previously diagnosed with certain types of cancer and in combination with certain drugs. The designation will help accelerate FDA assessment and review of Signatera as an in vitro diagnostic for use in pharmaceutical trials.
FDA has granted Breakthrough Device designation for MI Transcriptome companion diagnostic test.
The European Commission has granted conditional marketing authorization to Pfizer Inc. for Lorviqua (lorlatinib, available in the U.S., Canada, and Japan under the brand name Lorbrena), as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor therapy, or crizotinib and at least one other ALK TKI.
Arcus Biosciences Inc. and Strata Oncology Inc. entered into a clinical development collaboration utilizing Strata's precision drug development platform and proprietary biomarkers to evaluate AB122, Arcus's clinical-stage anti-PD-1 antibody, in a basket trial including tumor types that are generally not responsive to anti-PD-1 therapy.
FDA approved a supplemental New Drug Application to update the U.S. Prescribing Information for Tibsovo, an isocitrate dehydrogenase-1 inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation as detected by an FDA-approved test who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending Talzenna (talazoparib), an oral poly polymerase inhibitor.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion for the marketing authorization of Libtayo (cemiplimab).
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion, recommending Lynparza (olaparib) as a first-line maintenance treatment of BRCA-mutated advanced ovarian cancer.
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Grasustek, intended for prophylaxis against neutropenia in adult patients treated with cytotoxic chemotherapy. The applicant for this medicinal product is Juta Pharma GmbH.
