Industry News

FDA Expands Pediatric Indication for Entrectinib and Approves New Pellet Formulation

On October 20, 2023, the US Food and Drug Administration (FDA) granted accelerated approval to entrectinib for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have progressed following treatment or have no satisfactory standard therapy.
For more information read the FDA announcement.
Posted 10/20/2023

FDA Approves Nivolumab for Adjuvant Treatment of Stage IIB/C Melanoma

On October 13, the US Food and Drug Administration (FDA) approved nivolumab for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older.
For more information read the FDA announcement and the Bristol-Myers Squibb announcement.
Posted 10/16/2023

FDA Approves Encorafenib + Binimetinib for NSCLC with a BRAF V600E Mutation

On October 11, the US Food and Drug Administration (FDA) approved encorafenib in combination with binimetinib for adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
For more information read the FDA announcement and the Pfizer announcement.
Posted 10/12/2023

FDA Approves Momelotinib For Myelofibrosis Patients with Anemia

On September 15, the US Food and Drug Administration (FDA) approved momelotinib for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia.
For more information read the GSK announcement.
Posted 9/21/2023

FDA Approves Luspatercept-aamt for Adults with Lower-Risk MDS

On August 28, the US Food and Drug Administration (FDA) approved luspatercept-aamt for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions.
For more information read the Bristol Myers Squibb’s announcement.
Posted 8/31/2023

FDA Grants Accelerated Approval to Elranatamab-bcmm for Multiple Myeloma

On August 14, the US Food and Drug Administration (FDA) granted accelerated approval to 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.
For more information read the FDA announcement and Pfizer announcement.
Posted 8/15/2023

FDA Approves Niraparib and Abiraterone acetate + Prednisone for BRCA-mutated mCRPC

On August 11, the US Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA-mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.
For more information read the FDA announcement and the Janssen announcement.
Posted 8/15/2023

FDA Approves Talazoparib + Enzalutamide for HRR Gene-mutated Metastatic Castration-resistant Prostate Cancer

On June 20, the US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer.
For more information read the FDA announcement and the Pfizer announcement.
Posted 6/21/2023

FDA Approves Olaparib + Abiraterone and Prednisone for BRCA-mutated Metastatic Prostate Cancer

On May 31, the U.S Food and Drug Administration (FDA) approved olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.
For more information read the FDA announcement.
Posted 5/31/2023