Tools: Vol. 41, No. 5

Approved Drugs

• On July 9, 2026, the FDA approved Sarclisa Escena (isatuximab-irfc) (Sanofi-Aventis) for subcutaneous injection for multiple myeloma indications.
• On July 10, the FDA approved Keytruda® (pembrolizumab) (Merck) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) (Merck) each in combination with Padcev® (enfortumab vedotin-ejfv) (Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer.
• On July 14, the FDA granted traditional approval to Retevmo® (selpercatinib) (Eli Lilly) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with an 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.
• On July 14, the FDA approved Revtorpyk™ (gedatolisib) (Celcuity) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
• On July 22, the FDA approved Jideytro (zidesamtinib) (Nuvalent) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received at least one prior ROS1 tyrosine kinase inhibitor.
• On July 31, the FDA approved Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) (Novartis) 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 (previously referred to as metastatic hormone-sensitive prostate cancer).
• On August 6, the FDA granted accelerated approval to Tudriqev™ (vusolimogene oderparepvec-wtpg) (Replimune), 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.
• On August 13, the FDA granted accelerated approval to Zenbexus™ (iberdomide) (Bristol-Myers Squibb) 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.
• On August 25, the FDA approved Ziihera® (zanidatamab-hrii) (Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and Tevimbra® (tislelizumab-jsgr) (BeOne Medicines), 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. That same day the FDA approved Ziihera 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.
• On August 26, the FDA approved Rasonque™ (daraxonrasib) (Revolution Medicines), 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.

Drugs in the News

• The FDA granted breakthrough therapy and fast track designations to 68Ga-NYM096 (Norroy Bioscience), a potential radiopharmaceutical imaging agent targeting carbonic anhydrase IX for PET imaging of clear cell renal cell carcinoma.
• The FDA granted priority review to the supplemental biologics license application for subcutaneous amivantamab and hyaluronidase-lpuj (Johnson & Johnson) for adults with recurrent or metastatic head and neck squamous cell carcinoma.
• The FDA granted orphan drug designation to BAL0891 (SillaJen) for acute myeloid leukemia.
• The FDA granted fast track designation to BH-30643 (BlossomHill Therapeutics) for the treatment of adult patients with advanced or metastatic epidermal growth factor receptor (EGFR) C797S-positive non-small cell lung cancer after prior treatment with a third-generation EGFR tyrosine kinase inhibitor.
• The FDA granted fast track designation to BI-1808 (BioInvent), a first-in-class anti-TNFR2 antibody, for the treatment of ovarian cancer in combination with pembrolizumab.
• The FDA granted regenerative medicine advanced therapy and fast track designations to cemacabtagene ansegedleucel (Allogene Therapeutics) for the treatment of adult patients with large B-cell lymphoma who, at the completion of first-line therapy, are in complete or partial response suitable for observation but test positive for minimal residual disease.
• The FDA granted fast track designation to CT-P73 (Celltrion), an antibody drug conjugate, for recurrent or metastatic cervical cancer.
• The FDA accepted for filing the new drug application and granted priority review for D-PLEX100 (PolyPid) for the prevention of surgical site infections in patients undergoing abdominal colorectal surgery.
• The FDA granted fast track designation to SYS6090 (JMT108) (CSPC Pharmaceutical), a PD-1/IL-15 bispecific fusion protein, for the treatment of patients with microsatellite-stable or proficient mismatch repair metastatic colorectal cancer who have progressed on standard systemic therapies.
• The FDA accepted for priority review a supplemental new drug application for Talzenna® (talazoparib) (Pfizer), an oral poly ADP-ribose polymerase inhibitor, in combination with Xtandi® (enzalutamide), an androgen receptor pathway inhibitor, in men with homologous recombination repair gene-altered metastatic castration-sensitive prostate cancer.
• The FDA granted fast track designation to Varseta-M (CytomX Therapeutics) for the treatment of patients with relapsed/refractory metastatic colorectal cancer.
• The FDA granted orphan drug designation to zocilurtatug pelitecan (zoci, formerly ZL-1310) (Zai Lab), a Delta-like ligand 3 antibody-drug conjugate, for the treatment of neuroendocrine carcinomas.

Devices and Assays

• The FDA 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 (Ventana Medical Systems/Roche Diagnostics), 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.
• The FDA granted breakthrough device designation to SimpleScreen™ Lung (Freenome), an investigational lung cancer screening test.
• The FDA granted breakthrough device designation to SPOT-MAS 10 (Gene Solutions), an AI-powered, multi-omic platform for early cancer detection.