On August 26, the FDA approved daraxonrasib, an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

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

On August 25, the FDA approved zanidatamab-hrii:

in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr, as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and

in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.

The FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, for identifying patients with HER2-positive (IHC3+ or IHC2+/ISH+) gastric, gastroesophageal junction, and esophageal adenocarcinoma for treatment with Ziihera, consistent with the approved drug labeling.

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

On August 13, the FDA granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

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

On August 6, the FDA granted accelerated approval to vusolimogene oderparepvec-wtpg, a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1-blocking antibody-based regimen.

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

On July 31, the FDA approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naïve or-sensitive prostate cancer.

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

On July 22, the FDA approved zidesamtinib, an ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received a prior ROS1 kinase inhibitor.

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

On July 14, the FDA granted traditional approval to selpercatinib for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

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

On July 10, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, each in combination with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer.

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

On July 9, the FDA approved isatuximab-irfc for subcutaneous injection for multiple myeloma indications.

For more information, read the FDA announcement and the Sanofi-Aventis press release.

On June 24, the FDA approved sacituzumab govitecan-hziy for 2 indications in adults with triple-negative breast cancer.

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

On June 24, the FDA approved palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

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

On June 12, the FDA approved capivasertib in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer (previously referred to as metastatic hormone-sensitive prostate cancer) that is PTEN-deficient as detected by an FDA-authorized test.

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

On June 12, the FDA approved belzutifan in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph for the adjuvant treatment of adults with renal cell carcinoma with a clear cell component at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

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

On May 28, the FDA approved durvalumab in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer.

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

On May 27, the FDA approved pivekimab sunirine-pvzy, a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm.

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

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 .