Kristi Rosa

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in November 2025 spanning tumor types.

Phase 2 study finds 177Lu-Dotatate safe in advanced intracranial meningioma, with a 6-month PFS rate surpassing historical benchmarks.

Long-term ReNeu results showed deeper, more durable responses to mirdametinib in NF1-PN with extended treatment in both adults and children.

The FDA OKs the Oncomine Dx Target Test to identify patients with HER2 TKD–mutant NSCLC eligible for sevabertinib, enabling targeted treatment selection.

Mecbotamab vedotin showed promising survival gains and manageable safety in treatment-refractory soft tissue sarcomas.

The FDA has granted traditional approval to tarlatamab-dlle (Imdelltra) for the treatment of select patients with ES-SCLC.

Cemiplimab wins EU approval after C-POST shows DFS gains for high-risk CSCC, marking the first effective adjuvant immunotherapy option.

Gedatolisib’s NDA filing to the FDA is supported by VIKTORIA-1 data showing marked PFS improvements in HR+/HER2– advanced breast cancer.

Tafasitamab plus lenalidomide/rituximab cut progression risk by over 50% in relapsed follicular lymphoma, supporting its approval as a key second-line option.

Zanidatamab-based regimens improved PFS and OS vs chemotherapy in HER2+ gastroesophageal adenocarcinoma, positioning the agent as a potential new standard.

AMT-253 delivered durable responses in patients with melanoma with manageable toxicity, supporting continued development.

STK-012 plus pembrolizumab and chemotherapy showed early efficacy and manageable safety in PD-L1–negative NSCLC.

Here is your snapshot of all oncologic therapeutic options that were approved by the EMA in October 2025.

Darovasertib plus crizotinib improved OS to 21.1 months and boosted response rates in first-line metastatic uveal melanoma vs historical approaches.

Vepdegestrant maintained QOL and reduced risk of symptom deterioration vs fulvestrant in ESR1-mutated ER-positive, HER2-negative advanced breast cancer.

FDA grants fast track status to MT-125, a first-in-class NMII inhibitor, aiming to bring a novel treatment option to patients with aggressive glioblastoma.

Neladalkib showed durable responses and good tolerability in ALK-positive solid tumors, including TKI-pretreated patients, in early ALKOVE-1 results.

Switching to camizestrant plus a CDK4/6 inhibitor delayed symptom deterioration and improved QOL in HR+ breast cancer with the emergence of ESR1 mutations.

The FDA granted fast track to EO2463, an OncoMimics immunotherapy, for low–tumor burden follicular lymphoma in the watch-and-wait setting.

The FDA granted fast track to NBM-BMX, a HDAC8 inhibitor, for metastatic uveal melanoma.

Dato-DXd improved PFS, OS, and response rates compared with chemotherapy in first-line TNBC, with manageable safety, per phase 3 TROPION-Breast02 data.

Ivonescimab plus chemotherapy improved PFS and response rates vs tislelizumab in advanced squamous NSCLC, with a manageable safety profile.

I-DXd showed intracranial efficacy and manageable safety in ES-SCLC with brain metastases, per data from the IDeate-Lung01 study.

Enfortumab vedotin plus pembrolizumab significantly improved survival and pCR vs surgery alone in cisplatin-ineligible MIBC per KEYNOTE-905 data.

SunRISe-4 data show that TAR-200 and cetrelimab led to a high pCR and 12-month RFS rate in muscle-invasive bladder cancer.

NorthStar findings support osimertinib plus local consolidative therapy in EGFR-mutant non–small cell lung cancer.

MNV-201 has received orphan drug designation from the FDA for use in myelodysplastic syndrome.

NG-350A has been awarded fast track designation from the FDA for rectal cancer and is under further evaluation in the FORTRESS trial.

The approval of relacorilant for use in patients with platinum-resistant ovarian cancer is sought from the European Medicines Agency.

The AMPLITUDE trial met its primary end point of rPFS with niraparib regimen vs placebo in metastatic castration-sensitive prostate cancer.