ONCOLOGY NEWSFEED

On March 19, the US Food and Drug Administration (FDA) granted traditional approval to pembrolizumab with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1.

For more information read the FDA announcement .

On March 11, the European Commission granted marketing authorization for imetelstat as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low, or intermediate-risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic abnormality who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.

For more information, read the Geron press release .

On March 4, the US Food and Drug Administration (FDA) approved tislelizumab-jsgr in combination with platinum-containing chemotherapy for the first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.

For more information, read the Beigene press release .

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.

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 .

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 .

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 .

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.

Effective January 1, 2025, patients with Aetna® Medicare Advantage or SilverScript® coverage who have metastatic hormone-sensitive prostate cancer (mHSPC) and are new to NUBEQA® are subject to new prior authorization (PA) criteria. Some patients may be required to step through another medication before a PA for NUBEQA is approved. Patients with other Aetna plans, including commercial and Medicaid plans, other CVS Caremark® formularies, and plans through other insurance carriers are not affected. Additionally, mHSPC patients already on NUBEQA and patients with non-metastatic castration-resistant prostate cancer are not affected.

To learn more, visit Bayer Access Services .

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

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

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 .

On November 20, the US Food and Drug Administration (FDA) granted accelerated approval to zanidatamab-hrii, a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive IHC 3+ biliary tract cancer, as detected by an FDA-approved test.

For more information read the FDA announcement and the Jazz Pharmaceuticals press release .