FDA has approved Libtayo (cemiplimab-rwlc) in combination with platinum-based chemotherapy for adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
FDA has approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer with no sensitizing EGFR mutation or anaplastic lymphoma kinase genomic tumor aberrations.
FDA approved Adcetris (brentuximab vedotin) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients 2 years of age and older with previously untreated high risk classical Hodgkin lymphoma. This is the first pediatric approval for Adcetris.
Portage Biotech Inc., a clinical-stage immuno-oncology company focused on overcoming cancer treatment resistance, entered into an agreement with Merck.
FDA issued a revised draft guidance for industry, “Expanded Access to Investigational Drugs for Treatment Use Questions and Answers.”
Veeva Systems formed a ten-year strategic partnership agreement with Merck, that builds on the existing 12-year partnership between the companies. Under the terms of the agreement, Merck will take a Veeva-first approach to new industry-specific software and data, selecting Veeva products when they are fit for purpose to maximize the value of Veeva’s integrated, cloud-based platform and products.
Carrum Health and AccessHope LLC formed a collaboration to bring cancer expertise to people living with cancer.
FDA approved Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) for adult patients with unresectable hepatocellular carcinoma.
FDA granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
FDA issued marketing denial orders for several e-cigarette products currently marketed by Logic Technology Development LLC.
