July 14, 2026

Gedatolisib Combinations Approved by FDA for HR-Positive/HER2-Negative Breast Cancer

On July 14, the U.S. Food and Drug Administration (FDA) approved gedatolisib (Revtorpyk) in combination with fulvestrant, with or without palbociclib, for the treatment of adults with hormone receptor...

The ASCO Post

July 14, 2026

FDA Grants Traditional Approval to Selpercatinib for Locally Advanced or Metastatic RET Fusion–Positive Solid Tumors

Today, the FDA approved the oral RET inhibitor for adult and pediatric patients aged 2 years and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-ap...

The ASCO Post

July 10, 2026

FDA Approves Pembrolizumab or Pembrolizumab and Berahyaluronidase Alfa-pmph—Each With Enfortumab Vedotin-ejfv—for Muscle-Invasive Bladder Cancer

The FDA approved the PD-1 inhibitor pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex), each in combination with the NECTIN4-directed antibody-drug conjugate enf...

The ASCO Post

July 01, 2026

Breast Cancer: Palbociclib-Based Regimen Approved for HR-Positive, HER2-Positive Metastatic Disease

The U.S. Food and Drug Administration (FDA) has approved palbociclib (Ibrance) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult...

The ASCO Post

June 18, 2026

FDA Warns of Ongoing Breast Biopsy Needle Shortage

The U.S. Food and Drug Administration (FDA) issued notice of supply chain interruptions for stereotactic breast biopsy needles due to recent supplier issues. The agency noted that the duration of the ...

The ASCO Post

May 27, 2026

BPDCN: FDA Approves Pivekimab Sunirine-pvzy

Today, the FDA approved pivekimab sunirine-pvzy (Decnupaz), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The ASCO Post

May 26, 2026

FDA Approves Zenocutuzumab-zbco for Advanced, Unresectable, or Metastatic NRG1-Mutated Cholangiocarcinoma

The U.S. Food and Drug Administration (FDA) approved the HER2- and HER3-directed bispecific antibody, zenocutuzumab-zbco (Bizengri), for adults with advanced, unresectable, or metastatic cholangiocarc...

The ASCO Post

February 24, 2026

FDA Approves Pembrolizumab With Paclitaxel for Platinum-Resistant Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma

On February 10, the U.S. Food and Drug Administration (FDA) approved the PD-1 inhibitor pembrolizumab (Keytruda) as well as pembrolizumab and the recombinant human enzyme,berahyaluronidase alfa-pmph (...

The ASCO Post

February 23, 2026

FDA Releases Draft Guidance for Use of MRD and CR as Primary Endpoints in Multiple Myeloma Trials

On January 20, 2026, the U.S. Food and Drug Administration (FDA) released a draft guidance for industry regarding the use of minimal residual disease and complete response as primary endpoints in clin...

The ASCO Post

February 06, 2026

FDA Provides Safety Labeling Update for Capecitabine and Fluorouracil on Risks Associated With DPD Deficiency

The FDA has provided communication to increase awareness of recent updates to the product labeling of capecitabine (Xeloda) and fluorouracil—indicated for colorectal, breast, gastric/esophageal/gastro...

The ASCO Post