Mission Bio has developed a single-cell measurable residual disease assay that aims to advance personalized healthcare for patients with blood cancer.
FDA has approved Ojjaara (momelotinib) for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythaemia vera and post-essential thrombocythemia), in adults with anemia.
FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk, locally advanced cervical cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
The Committee for Medicinal Products for Human Use of the European Medicine Agency has adopted a positive opinion for the extension of the marketing authorization of Adcetris (brentuximab vedotin) and recommended its approval in combination with doxorubicin, vinblastine, and dacarbazine—or AVD—in adult patients with previously untreated CD30+ stage 3 Hodgkin lymphoma.
FDA approved Akeega (niraparib and abiraterone acetate), a dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, for the treatment of adult patients with deleterious or suspected deleterious BRCA-positive mCRPC, as detected by an FDA-approved test.
On Sept. 14, FDA approved updated labeling for Temodar (temozolomide) under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for older oncology drugs to ensure information is clinically meaningful and scientifically up-to-date.
Flatiron Health and FDA’s Oncology Center of Excellence renewed their collaboration to jointly develop and implement specific research projects to advance the use of real-world data and explore the potential strengths and limitations of using real-world evidence for regulatory purposes. The partnership will specifically evaluate RWD study designs and analytic methods through the collaborative development of priority, clinically meaningful research questions regarding care, treatment, and outcomes of patients with cancer.
Pierre Fabre Laboratories, the French pharmaceutical and dermo-cosmetic company, announced the acquisition of Vertical Bio AG, a developer of novel cancer therapies.
FDA granted accelerated approval to Elrexfio (elranatamab-bcmm), a bispecific B-cell maturation antigen-directed CD3 T-cell engager, 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.
