FDA has approved Genentech’s Tecentriq (atezolizumab) as an adjuvant treatment following resection and platinum-based chemotherapy in patients with stage 2 to 3A non-small cell lung cancer whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
Verzenio (abemaciclib) with endocrine therapy (tamoxifen or an aromatase inhibitor) received FDA approval for adjuvant treatment of adult patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%, as determined by an FDA approved test.
Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, received FDA approval for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.
The FDA issued marketing orders for the first e-cigarette products authorized by the agency.
The Swiss Agency for Therapeutic Products (Swissmedic) has granted approval for Qinlock (ripretinib) for the treatment of adult patients with advanced gastrointestinal stromal tumor who have received prior treatment with three or more kinase inhibitors, including imatinib1.
Mayo Clinic Cancer Center, Mayo Clinic’s Department of Laboratory Medicine and Pathology, and Mayo Clinic’s Center for Individualized Medicine and Personalis Inc. have formed a collaboration to expand cancer genomic testing.
The Innovative Medicines Initiative, a joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations, launched OPTIMA, a €21.3 million public-private research program that will seek to use artificial intelligence to improve care for patients with prostate, breast, and lung cancer.
Pillar Biosciences has entered into an agreement with Labcorp to provide genomic testing for people with cancer.
Tecartus (brexucabtagene autoleucel) received FDA approval for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
The FDA granted recognition to a partial listing of the Memorial Sloan Kettering Cancer Center’s Oncology Knowledge Base (OncoKB) as the first tumor mutation database to be included in the Public Human Genetic Variant Databases.