Jason M. Broderick

Long-term real-world safety and effectiveness of darbepoetin alfa in MDS-related anemia are consistent with registration trial findings.

Investigators urge caution in interpreting these results, acknowledging the inherent limitations of unanchored, population-adjusted indirect trial comparisons.

The TRITON3 update supports rucaparib's role as an established option in the post-ARPI, pre-chemotherapy BRCA+ mCRPC setting.

"Sac-TMT may be able to address a critical unmet need for certain patients with advanced endometrial cancer," said Domenica Lorusso, MD, PhD.

The neoadjuvant and adjuvant FDA indications for T-DXd in HER2+ breast cancer are based on the DESTINY-Breast11 and DESTINY-Breast05 trials, respectively.

In ARASEC, darolutamide plus ADT significantly improved survival and disease control versus ADT alone in mHSPC, complementing ARANOTE outcomes.

The FDA approved atezolizumab for the adjuvant treatment of muscle invasive bladder cancer with ctDNA molecular residual disease after cystectomy.

UGN-103 (mitomycin) for intravesical solution sustained disease control through 6 months in the UTOPIA trial in recurrent intermediate-risk LG-NMIBC.

The FDA has granted suplexa, a non-engineered autologous cellular immunotherapy, fast track designation for patients with MSI-H colorectal cancer.

The phase 3 VOLGA trial showed perioperative durvalumab plus neoadjuvant enfortumab vedotin reduced the risk of death in muscle-invasive bladder cancer.

Mitomycin for intravesical solution demonstrated durable responses in 36-month follow-up data from the phase 3 ENVISION trial.

Sexual activity, sexual desire, and physical function were improved by testosterone replacement therapy in men with hypogonadism post-prostatectomy.

Emiltatug ledadotin is a B7-H4–directed antibody-drug conjugate that has shown antitumor activity in adenoid cystic carcinoma and other solid tumors.

The DLL3-targeting antibody-drug conjugate zocilurtatug pelitecan has elicited antitumor activity across subtypes of extrapulmonary neuroendocrine carcinomas.

INBRX-106 may act as a costimulatory agent and enhance pembrolizumab outcomes in head and neck squamous cell carcinoma.

The FDA has approvesd zenocutuzumab-zbco for previously treated NRG1 fusion–positive cholangiocarcinoma cholangiocarcinoma.

The FDA previously granted RZ-001 both orphan drug designation and fast track designation for hepatocellular carcinoma.

The phase 1/2 data led to the phase 3 RASolute 302 trial which supported the FDA's allowance of early access to daraxonrasib in PDAC.

Intraperitoneal rintatolimod may boost outcomes with immunotherapies such as pembrolizumab in ovarian cancer.

The FDA has authorized expanded access to the RAS inhibitor daraxonrasib for patients with previously treated metastatic pancreatic ductal adenocarcinoma.

Darlifarnib may enable the rechallenging of patients with cabozantinib in a combination context for patients with clear cell renal cell carcinoma.

Mirvetuximab soravtansine plus carboplatin showed promise in patients with FRα-positive platinum-sensitive ovarian cancer.

The novel FRα-targeted ADC sofetabart mipitecan showed strong antitumor activity in patients with heavily pretreated platinum-resistant ovarian cancer.

A new integrated treatment regimen significantly enhances PFS vs standard chemotherapy in metastatic pancreatic cancer.

Imlunestrant shows significant progression-free survival benefits in advanced breast cancer, offering a promising treatment option for patients.

The MajesTEC-3 trial showed that teclistamab combined with subcutaneous daratumumab improved overall survival vs standard daratumumab-based regimens in relapsed/refractory multiple myeloma.

Pirtobrutinib shows superior overall response rates and promising progression-free survival compared to ibrutinib in treating chronic lymphocytic leukemia.

Gintemetostat shows promising efficacy and safety in heavily pretreated multiple myeloma patients, paving the way for future combination therapies.

The FDA has granted a full approval to tarlatamab-dlle for extensive-stage small cell lung cancer.

The FDA has approved sevabertinib for HER2-mutant nonsquamous non–small cell lung cancer.