Precision Medicine in Oncology®

The FDA has granted traditional approval to pembrolizumab for unresectable/metastatic TMB-H solid tumors.

Invikafusp alfa now holds fast track status across TMB-H solid tumors that progressed after prior therapy, including checkpoint inhibition.

The liquid biopsy identifies ESR1 mutations in blood to select patients with metastatic breast cancer who may be eligible for treatment with camizestrant.

Natera’s blood-based, cell-free DNA multi-cancer early detection assay received the designation after the FDA reviewed data spanning 12 cancer types.

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in September 2026 spanning tumor types.

TRE-515 earned fast track status in combination with KRAS inhibitors for G12C-mutated NSCLC after anti–PD-(L)1 therapy and platinum-based chemotherapy.

An NDA for zipalertinib in EGFR exon 20 insertion–positive NSCLC is being supported by phase 3 REZILIENT3 data.

The top 5 OncLive TV videos of the week cover insights in breast cancer, PV, myeloma, and CLL.

The FDA approved lirafugratinib in FGFR2+ cholangiocarcinoma and belzutifan plus lenvatinib in advanced ccRCC, and more.

The addition of the β-catenin pathway inhibitor tegavivint to osimertinib produced deep responses in a phase 1b study in first-line EGFR-mutated NSCLC.

The FDA has cleared an sNDA updating the taletrectinib (Ibtrozi) label with new DOR data in TKI-naive patients with locally advanced or metastatic ROS1-positive NSCLC.

KST-6051 received FDA fast track designation for KRAS-mutant solid tumors.

The FDA approved sevabertinib in first-line HER2-mutant lung cancer, durvalumab plus tarlatamab boosted survival in ES-SCLC, and more.

The conditional approval of fanregratinib is supported by pivotal phase 2 data showing a 42.5% objective response rate in pretreated FGFR2-altered intrahepatic cholangiocarcinoma.

UroGen submitted an NDA for UGN-103 in recurrent NMIBC, T-DXd improved PFS in first-line HER2-mutant lung cancer, and more.

The oral PARG inhibitor ETX-19477 earned fast track status for BRCA-mutated, HR-positive, HER2-negative unresectable or metastatic breast cancer.

The top 5 OncLive TV videos of the week cover insights in melanoma, prostate cancer, breast cancer, multiple myeloma, and small cell lung cancer.

The FDA approved RP1 plus nivolumab in advanced melanoma, granted olomorasib breakthrough status in KRAS G12C+ pancreatic cancer, and more.

PD-L1 IHC 22C3 pharmDx gained EU approval as a companion diagnostic for pembrolizumab in platinum-resistant epithelial ovarian cancer.

The FDA has approved zidesamtinib in patients with locally advanced/metastatic ROS1+ NSCLC who received a prior ROS1 kinase inhibitor.

The FDA approved gedatolisib in PIK3CA wild-type breast cancer, granted full approval to selpercatinib in RET fusion+ tumors, and more.

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