Surface Oncology and Merck have entered into a clinical trial collaboration to evaluate the safety and efficacy of combining Surface’s SRF388, an investigational antibody therapy targeting IL-27, with Merck’s Keytruda (pembrolizumab), an anti-PD-1 therapy.
Syapse has renewed its strategic collaboration with Pfizer.
FDA has granted regular approval to Lorbrena (lorlatinib) for patients with metastatic non-small cell lung cancer whose tumors are anaplastic lymphoma kinase-positive, detected by an FDA-approved test.
FDA has authorized marketing of the Hominis Surgical System, a new robotically-assisted surgical device that can help facilitate transvaginal hysterectomy in certain patients.
FDA has granted accelerated approval to Pepaxto (melphalan flufenamide) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a second indication for Sarclisa (isatuximab), in combination with carfilzomib and dexamethasone (Kd), for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended approval of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) for the first-line treatment of adults with advanced renal cell carcinoma.
The Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion recommending dostarlimab as monotherapy in women with mismatch repair deficient/microsatellite instability-high recurrent or advanced endometrial cancer who have progressed on or following prior treatment with a platinum containing regimen.
Novartis said it has closed the in-licensing of tislelizumab from BeiGene, Ltd. in North America, Europe and Japan. Tislelizumab is a uniquely designed anti-PD-1 antibody, specifically engineered to minimize binding to FcyR on macrophages, that is approved in China for certain patients with non-small cell lung cancer, classical Hodgkin’s lymphoma and metastatic urothelial carcinoma.
FDA has approved Libtayo (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations.
