FDA fast-tracks QTX-2101, an oral arsenic trioxide therapy, enhancing treatment accessibility for acute promyelocytic leukemia patients.
February 2026 Brief
FDA reviews zanzalintinib and atezolizumab for metastatic colorectal cancer, offering hope for patients with limited treatment options.
The FDA granted orphan drug designation to IFx-2.0, an injection designed to enhance immune response, in cutaneous melanoma.
FDA prioritizes review of datopotamab deruxtecan for treating metastatic triple-negative breast cancer, showing significant survival benefits over chemotherapy.
FDA reviews new drug applications for rivoceranib and camrelizumab as first-line treatments for advanced liver cancer, promising improved survival rates.
FDA fast-tracks pelareorep with bevacizumab and FOLFIRI for KRAS-mutant MSS metastatic colorectal cancer, after standout response and survival signals.
FDA clears mRNA-based HPV test for primary screening, helping clinicians spot cancer-driving infections, cut overtreatment, and personalize care.
FDA strengthens capecitabine and 5‑FU labels: DPD deficiency can trigger fatal toxicity; consider testing, lower doses, and prompt antidote.
FDA lifts Yescarta limits for relapsed primary CNS lymphoma, expanding CAR T access with phase 1 safety data—what to know about neuro risks.
FDA RMAT boosts inhaled gene therapy KB707, delivering IL‑2/IL‑12 to lung tumors; early trial shows responses with manageable safety.
FDA fast-tracks irpagratinib for FGF19+ advanced liver cancer, with early trials showing strong response rates and ongoing combo study momentum.
FDA approves Optune Pax, a wearable tumor treating fields device, to pair with GnP chemo in locally advanced pancreatic cancer, extending survival and delaying pain.
FDA accepts Ameluz PDT sNDA for superficial basal cell carcinoma, with strong phase 3 clearance data and a September 2026 decision deadline.
FDA grants orphan drug designation to HCB101 for gastric cancer; early trials suggest safer CD47 checkpoint blockade with promising tumor control in advanced settings.
FDA approves monthly subcutaneous amivantamab plus lazertinib for EGFR-mutated advanced NSCLC, cutting clinic time and infusion reactions while maintaining efficacy.
The FDA accepted the new drug application for iberdomide based on minimal residual disease negativity benefit shown in the EXCALIBER-RRMM trial.
FDA accepts tirabrutinib for accelerated review in relapsed/refractory CNS lymphoma, spotlighting strong phase 2 responses and a needed U.S. option.
The FDA granted breakthrough therapy designation to Rybrevant Faspro based on data from the phase 1b/2 OrigAMI-4 study (NCT06385080).
FDA approves 14‑month, all‑oral acalabrutinib plus venetoclax first-line for CLL/SLL, boosting progression-free survival and offering a fixed-duration alternative to chemo.
FDA reviews oral giredestrant plus everolimus for ESR1-mutated ER+ metastatic breast cancer after CDK4/6 failure, with strong PFS gains and manageable safety.
FDA fast-tracks PLT012, a CD36 metabolic checkpoint antibody for liver cancer, as phase 1 trial tests safety and early efficacy.
FDA fast tracks ART6043, an oral Polθ inhibitor for gBRCA HER2-negative metastatic breast cancer, showing early activity and potential to overcome PARP resistance.
FDA confirms first-line BRAF V600E mCRC gains: encorafenib plus cetuximab with FOLFOX or FOLFIRI improves PFS and OS.
FDA clears zongertinib for HER2-mutant advanced nonsquamous NSCLC, showing strong responses and promising brain metastasis activity.
AKY-1189 gains fast track designation in urothelial cancer.
FDA clears real-time AI OCT to spot breast cancer margins during lumpectomy, helping surgeons reduce repeat operations and improve outcomes.
The FDA granted approval of the combination of teclistamab and daratumumab for patients with 1-3 prior lines of therapy in myeloma.