FDA Approves Fam-Trastuzumab Deruxtecan-Nxki for Unresectable or Metastatic HR-positive, HER2-low or HER2-ultralow Breast Cancer

On January 27, the US Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting.

For more information, read the FDA announcement and the Daiichi Sankyo press release.

Posted on 2/20/25

FDA Approves Vimseltinib for Symptomatic Tenosynovial Giant Cell Tumor

On February 14, the US Food and Drug Administration (FDA) approved vimseltinib, a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumors for which surgical resection will potentially cause worsening functional limitation or severe morbidity. 

For more information, read the FDA announcement and the Deciphera press release.

Posted on 2/17/25

FDA Approves Mirdametinib for Select Adult and Pediatric Patients With Neurofibromatosis Type 1

On February 11, the US Food and Drug Administration (FDA) approved mirdametinib for adults and children aged 2 years and older with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that cannot be completely resected.   

For more information, read the FDA announcement and the SpringWorks Therapeutics press release.

Posted on 2/12/2025

FDA Approves Brentuximab Vedotin With Lenalidomide and Rituximab for Relapsed or Refractory Large B-Cell Lymphoma

On February 11, the US Food and Drug Administration (FDA) approved brentuximab vedotin plus lenalidomide and rituximab for adults with relapsed or refractory large B-cell lymphoma who have undergone at least 2 lines of systemic therapy and are not candidates for autologous hematopoietic stem cell transplantation or CAR-T therapy. 

For more information, read the FDA announcement and the Pfizer press release.

Posted on 2/12/2025

FDA Approves Treosulfan With Fludarabine as a Preparative Regimen for alloHSCT in Adult and Pediatric Patients with AML or MDS

On January 21, the US Food and Drug Administration (FDA) approved treosulfan, an alkylating agent, with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients 1 year of age and older with acute myeloid leukemia or myelodysplastic syndrome.

For more information, read the FDA Announcement or the Medexus press release.

Posted on 2/7/2025

Patients New to Nubeqa Will be Subject to New Prior Authorization Criteria

FDA Approves Datopotamab Deruxtecan-dlnk for Unresectable or Metastatic, HR-positive, HER2-Negative Breast Cancer

On January 17, the US Food and Drug Administration (FDA) approved datopotamab deruxtecan-dlnk for adult patients with unresectable or metastatic, hormone receptor-positive, human epidermal growth factor receptor 2 negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

For more information, read the FDA announcement and the AstraZeneca press release.

Posted on 1/28/2025

FDA Safety Announcement on the Importance of DPD Deficiency Discussions With Patients Before Capecitabine or 5FU Treatment

On January 24, the US Food and Drug Administration (FDA) released new information to increase awareness of recent updates to capecitabine and fluorouracil product labeling related to risks associated with dihydropyrimidine dehydrogenase deficiency.

For more information, read the FDA announcement.

Posted on 1/28/2025

FDA Approves Sotorasib With Panitumumab for KRAS G12C-Mutated Colorectal Cancer

On January 16, US the Food and Drug Administration (FDA) approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. 

For more information read the FDA announcement and the Amgen press release.

Posted on 1/17/2025

FDA Approves Acalabrutinib With Bendamustine and Rituximab for Previously Untreated Mantle Cell Lymphoma

On January 16, the US Food and Drug Administration (FDA) granted traditional approval to acalabrutinib with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation.

For more information read the FDA announcement and the AstraZeneca press release.

Posted on 1/17/2025

FDA Approves Encorafenib Combination Regimen as First-Line Treatment of BRAF V600E-Mutant Metastatic Colorectal Cancer

On December 20, the US Food and Drug Administration (FDA) approved encorafenib in combination with cetuximab and fluorouracil, leucovorin, and oxaliplatin for the treatment of patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

For more information, read the Pfizer press release.

Posted on 1/13/2025

FDA Approves Tislelizumab-jsgr for First-line Treatment of Gastric and Gastroesophageal Junction Cancers

On December 27, the US Food and Drug Administration approved tislelizumab-jsgr in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.

For more information, read the BeiGene press release.

Posted on 1/2/2025

FDA Approves Nivolumab and Hyaluronidase-nvhy for Subcutaneous Injection

On December 27, the US Food and Drug Administration approved nivolumab and hyaluronidase-nvhy for subcutaneous injection across approved adult, solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab combination therapy, or in combination with chemotherapy or cabozantinib.

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

Posted on 1/2/2025

FDA Approves Blinatumomab for 72- and 96-Hour Infusion Durations

On December 17, the US Food and Drug Administration approved blinatumomab for 72- and 96-hour infusion durations to offer more flexibility for physicians and their patients.

For more information visit the BLINCYTO website.

Posted on 12/23/2024

FDA Grants Accelerated Approval to Encorafenib With Cetuximab and mFOLFOX6 for Metastatic Colorectal Cancer With a BRAF V600E Mutation

On December 20, the US Food and Drug Administration granted accelerated approval to encorafenib with cetuximab and mFOLFOX6 for patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test.

For more information read the FDA announcement and the Array BioPharma press release.

Posted on 12/23/2024

FDA Approves Remestemcel-L-rknd for Steroid-Refractory Acute Graft Versus Host Disease in Pediatric Patients

On December 18, the US Food and Drug Administration approved remestemcel-L-rknd, an allogeneic bone marrow-derived mesenchymal stromal cell therapy, for steroid-refractory acute graft versus host disease in pediatric patients 2 months of age and older.

For more information read the FDA announcement and visit the Mesoblast website.

Posted on 12/23/2024

FDA Approves Ensartinib for ALK-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer

On December 18, the US Food and Drug Administration approved ensartinib for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer who have not previously received an ALK-inhibitor.

For more information read the FDA announcement and visit the Xcovery Holdings website.

Posted on 12/23/2024

FDA Approves Cosibelimab-ipdl for Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma

On December 13, the US Food and Drug Administration approved cosibelimab-ipdl, a programmed death ligand-1 blocking antibody, for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. 

For more information read the FDA announcement and the Checkpoint Therapeutics press release.

Posted on 12/23/2024

FDA Approves Durvalumab for Limited-Stage Small Cell Lung Cancer

On December 4, the US Food and Drug Administration (FDA) approved durvalumab for adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

For more information, read the FDA announcement or the AstraZeneca press release.

Posted on 12/6/2024

FDA Grants Accelerated Approval to Zenocutuzumab-zbco for Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma

On December 4, US the Food and Drug Administration (FDA) granted accelerated approval to zenocutuzumab-zbco for adults with the following:

• advanced, unresectable, or metastatic non-small cell lung cancer harboring a neuregulin 1 (NRG1) gene fusion with disease progression on or after prior systemic therapy, or
• advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.

For more information, read the FDA announcement or the Merus N.V. press release. 

Posted on 12/6/2024