FDA approved Rybrevant (amivantamab-vmjw) with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
Elektrofi Inc., a biopharmaceutical formulation technology has entered a multi-target worldwide research collaboration and license agreement with Janssen Biotech Inc., a Johnson & Johnson company.
FDA granted accelerated approval to Talvey (talquetamab-tgvs) for adults 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.
Evotec entered into a strategic collaboration and license agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson. The collaboration focuses on the development of first-in-class targeted immune-based therapies for oncology, which will ultimately be commercialized by Janssen. The agreement was facilitated by Johnson & Johnson Innovation.
Four-year follow-up results from the phase III GLOW study showed that investigational, fixed-duration treatment with Imbruvica (ibrutinib) in combination with venetoclax reduced the risk of progression or death by 79% among older and/or unfit patients with previously untreated chronic lymphocytic leukemia compared to patients treated with chemoimmunotherapy.
Data from the phase III MAIA of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone in newly diagnosed, transplant-ineligible patients with multiple myeloma—regardless of patients’ age and across clinically important subgroups, as well as health-related quality of life among frail TIE patients—were presented in oral and poster presentations at the American Society of Hematology 2022 Annual Meeting.
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.
