FDA Approves Repotrectinib for Patients with NTRK Gene Fusion-Positive Solid Tumors

On June 13, the US Food and Drug Administration (FDA) granted accelerated approval to repotrectinib for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

For more information read the FDA announcement and the Bristol Meyers Squibb announcement.

Posted 7/2/2024 

FDA Grants Approves Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma

On June 26, the US Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

FDA Approves Adagrasib + Cetuximab for KRAS G12C-Mutated Colorectal Cancer

On June 21, the US Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

For more information read the FDA announcement and the Bristol Myers Squibb announcement. 

Posted 6/24/2024

FDA Approves Durvalumab + Chemotherapy for Endometrial Cancer

On June 17, the US Food and Drug Administration (FDA) approved durvalumab in combination with carboplatin and paclitaxel followed by durvalumab monotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. 

For more information read the AstraZeneca announcement. 

Posted 6/17/2024

FDA Approves Pembrolizumab + Chemotherapy for Primary Advanced or Recurrent Endometrial Carcinoma

On June 17, the US Food and Drug Administration (FDA) approved pembrolizumab in combination with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

For more information read the FDA announcement and the Merck announcement. 

Posted 6/17/2024

FDA Approves Selpercatinib for RET Fusion-Positive Thyroid Cancer

On June 12, the US Food and Drug Administration (FDA) approved selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).

For more information read the FDA announcement. 

Posted 6/13/2024

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 Idecabtagene vicleucel for Relapsed or Refractory Multiple Myeloma

On April 4, the US Food and Drug Administration (FDA) approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after 2 or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 

For more information read the Bristol Myers Squibb announcement.

Posted 4/9/2024

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

FDA Approves Mirvetuximab Soravtansine-gynx for Certain Ovarian Cancers

On March 22, the US Food and Drug Administration (FDA) approved mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens. 

For more information read the FDA announcement and the AbbVie announcement. 

Posted 3/25/2024

FDA Approves Oral Suspension Ibrutinib in Adults with Chronic Lymphocytic Leukemia & Small Lymphocytic Lymphoma

On February 24, the US Food and Drug Administration (FDA) approved a label expansion for ibrutinib with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Ibrutinib is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation.

For more information read the Johnson & Johnson announcement.

Posted 3/21/2024

FDA Approves Ponatinib + Chemotherapy for Lymphoblastic Leukemia

On March 19, the US Food and Drug Administration (FDA) granted accelerated approval to ponatinib in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.

For more information read the FDA announcement and the Takeda Pharmaceuticals announcement. 

Posted 3/20/2024

FDA Approves Tislelizumabjsgr for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

On March 14, the US Food and Drug Administration (FDA) approved tislelizumabjsgr as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor. 

For more information read the BeiGene announcement.

Posted 3/15/2024