Industry News

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

On January 17, the 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 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