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