Industry News

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 Trifluridine + Tipiracil with Bevacizumab for Previously Treated mCRC

On August 2, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.
For more information read the FDA announcement.
Posted 8/2/2023

FDA Approves Dostarlimab-gxly + Chemotherapy for Endometrial Cancer

On July 31, the US Food and Drug Administration (FDA) approved dostarlimab-gxly with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.
For more information read the FDA announcement and the GlaxoSmithKline announcement
Posted 8/2/2023

FDA Approves Quizartinib for Newly Diagnosed AML

On July 20, the US Food and Drug Administration (FDA) approved quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication-positive, as detected by an FDA-approved test.
For information read the FDA announcement and the Daiichi Sankyo, Inc. announcement.
Posted 7/21/2023

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 Grants Accelerated Approval to Glofitamab-gxbm

On June 15, the US Food and Drug Administration (FDA) granted accelerated approval to glofitamab-gxbm for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.
For more information read the FDA announcement and the Genentech announcement.
Posted 6/20/2023

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