FDA has granted priority review for Genentech's supplemental Biologics License Application for Tecentriq (atezolizumab) plus chemotherapy, Abraxane (albumin-bound paclitaxel; nab-paclitaxel) for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the PD-L1 protein, as determined by PD-L1 biomarker testing.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending an expanded indication for Kisqali (ribociclib), the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent, superior and sustained efficacy compared to endocrine therapy alone.
FDA approved Erleada (apalutamide) for the treatment of non-metastatic castration-resistant prostate cancer. This is the first FDA-approved treatment for this indication.
FDA has expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma.
FDA has approved Empliciti (elotuzumab) injection for intravenous use in combination with pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.
FDA has granted Fast Track designation to selinexor, Karyopharm Therapeutics Inc.'s first in class, oral SINE compound, for the treatment of patients with diffuse large B-cell lymphoma who have received at least two prior therapies and are not eligible for high dose chemotherapy with stem cell rescue or CAR-T therapy.
Seattle Genetics Inc. has submitted a supplemental Biologics License Application to FDA based on data from the phase III ECHELON-2 trial evaluating Adcetris (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
Bristol-Myers Squibb Co. and Infinity Pharmaceuticals Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb's Opdivo (nivolumab) in combination with Infinity's IPI-549 in patients with advanced urothelial cancer.
ASCO and the Society for Immunotherapy of Cancer released a joint statement with twelve clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immuno-oncology treatments.
Sandoz, a Novartis division focused on biosimilars, announced that it will not pursue its submission for biosimilar rituximab in the US at this time.
