Industry News

FDA Approves Imetelstat for Myelodysplastic Syndromes with Transfusion-Dependent Anemia

On June 6, the US Food and Drug Administration (FDA) approved imetelstat, an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia—requiring 4 or more red blood cell units over 8 weeks—who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents.
For more information read the FDA announcement and the Geron announcement.
Posted 6/7/2024

FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Mantle Cell Lymphoma

On May 30, the US Food and Drug Administration (FDA) approved lisocabtagene maraleucel for adult patients with relapsed or refractory mantle cell lymphoma who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.
For more information read the FDA announcement and the Bristol Meyers Squibb announcement.
Posted 6/4/2024

FDA Approves Tarlatamab-dlle for Extensive-Stage Small Cell Lung Cancer

On May 16, the US Food and Drug Administration granted accelerated approval to tarlatamab-dlle for extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
For more information read the FDA announcement and the Amgen Inc. announcement.
Posted 5/20/2024

FDA Approves Lisocabtagene Maraleucel for Follicular Lymphoma

On May 15, the US Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel for adults with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.
For more information read the FDA announcement.
Posted 5/16/2024

FDA Approves Tisotumab Vedotin-tftv for Recurrent or Metastatic Cervical Cancer

On April 29, the US Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.
For more information read the FDA announcement and the Pfizer announcement.
Posted 4/30/2024

FDA Approves Lutetium Lu 177 Dotatate for Pediatric Patients with Astroenteropancreatic Neuroendocrine Tumors

On April 23, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.
For more information read the FDA announcement.
Posted 4/24/2024

FDA Approves Nogapendekin Alfa Inbakicept-pmln for Invasive Bladder Cancer

On April 22, the US Food and Drug Administration approved nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
For more information read the FDA announcement.
Posted 4/23/2024

FDA Approves Alectinib for ALK-positive Non-Small Cell Lung Cancer

On April 18, the US Food and Drug Administration (FDA) approved alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test.
For more information read the FDA announcement and the Genentech Inc. announcement.
Posted 4/18/2024

FDA Approves Fam-trastuzumab deruxtecan-nxki for Unresectable or Metastatic HER2-positive Solid Tumors

On April 5, the US Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.
For more information read the FDA announcement.
Posted 4/8/2024