ONCOLOGY NEWSFEED

On May 22, the FDA approved datopotamab deruxtecan-dlnk for adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.

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

On May 15, the FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for 2 separate indications in adults with HER2-positive early-stage breast cancer. The first indication is for Enhertu followed by a taxane, trastuzumab, and pertuzumab, for the neoadjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) stage II or III breast cancer, as determined by an FDA-authorized test. The second indication is for Enhertu for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant treatment with trastuzumab (with or without pertuzumab) and taxane-based treatment.

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

On May 15, the FDA approved atezolizumab and atezolizumab and hyaluronidase-tqjs as adjuvant treatments for adults with muscle invasive bladder cancer after cystectomy who have circulating tumor DNA molecular residual disease as determined by an FDA-authorized test.

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

On May 13, the FDA approved an oral combination of decitabine and cedazuridine tablets with venetoclax for the treatment of newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy.

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

On May 13, the FDA granted accelerated approval to sonrotoclax, a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least 2 lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.

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

On May 8, the FDA approved zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion with disease progression on or after prior systemic therapy.

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

On May 1, the FDA approved vepdegestrant, a heterobifunctional protein degrader, for adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least 1 line of endocrine therapy.

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

On March 25, the FDA approved relacorilant, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens, at least 1 of which included bevacizumab.

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

On March 20, the FDA approved nivolumab with doxorubicin, vinblastine, and dacarbazine for adult and pediatric patients 12 years and older with previously untreated, Stage III or IV classical Hodgkin lymphoma.

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

On March 5, the FDA approved teclistamab in combination with daratumumab hyaluronidase-fihj for adult patients with relapsed or refractory multiple myeloma who have received at least 1 prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

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

On February 26, the FDA granted accelerated approval to zongertinib, a kinase inhibitor, for an expanded indication for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

For more information, read the FDA announcement and visit the Boehringer Ingelheim Pharmaceuticals website.

On February 24, the FDA granted traditional approval to encorafenib in combination with cetuximab and fluorouracil-based chemotherapy for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test.

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

On February 19, the FDA approved acalabrutinib tablets and capsules in combination with venetoclax for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma.

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

On February 11, the FDA approved Optune Pax® for the treatment of adult patients with locally advanced pancreatic cancer concomitant with gemcitabine and nab-paclitaxel.

For more information, read the Novocure press release .

On February 10, the FDA approved pembrolizumab as well as pembrolizumab and berahyaluronidase alfa-pmph in combination with paclitaxel, with or without bevacizumab, for adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumors express PD-L1 (CPS≥1) as determined by an FDA-authorized test, and who have received 1 or 2 prior systemic treatment regimens.

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

The FDA is providing this communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil (5-FU) related to risks associated with dihydropyrimidine dehydrogenase (DPD) deficiency. All health care providers should be aware of the risks of DPD deficiency, inform patients prior to treatment about the potential for serious and life-threatening toxicities due to DPD deficiency, and test patients for genetic variants of DPYD prior to initiating treatment with capecitabine or 5-FU unless immediate treatment is necessary.

For more information, read the FDA announcement .

On December 21, the FDA approved CD20xCD3 bispecific mosunetuzumab-axgb as a subcutaneous formulation for the treatment of adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy, based on results from the Phase I/II GO29781 study.

For more information, read the Genentech press release .

On January 27, the FDA approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

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

On January 16, 2026, Sun Pharmaceutical Industries announced that UNLOXCYT™ (cosibelimab-ipdl) is now available in the US for health care professionals to prescribe 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 Sun Pharmaceutical Industries press release .

On December 17, the FDA approved amivantamab and hyaluronidase-lpuj for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of amivantamab.

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

On December 17, the FDA approved rucaparib for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.

For more information, read the FDA announcement and visit the pharmaand website .

On December 15, the FDA approved fam-trastuzumab deruxtecan-nxki in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.

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

On December 12, the FDA approved niraparib and abiraterone acetate with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.

For more information, read the FDA announcement and visit the Janssen Biotech website .

On December 4, the FDA approved lisocabtagene maraleucel for adults with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.

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