April 2026 Brief

CB-011, an allogeneic CAR T product, received RMAT designation as treatment for multiple myeloma based on strong dose expansion data.

The FDA has extended the deadline to review Orca-T for the treatment of myelodsyplastic syndromes and acute leukemias with a PDUFA date of July 6, 2026.

The FDA granted breakthrough therapy designation to plixorafenib for adult patients with BRAF V600E–mutated high-grade glioma, based on data from a completed phase 1/2a trial and the ongoing phase 2 FORTE basket study.

FDA confirms brexu-cel CAR-T for relapsed mantle cell lymphoma, citing 91% response in BTK-naive patients and updated safety guidance.

The FDA granted fast track designation to PAS-004, a macrocyclic MEK inhibitor, for NF1-associated plexiform neurofibromas causing significant morbidity.

FDA fast track status for CTIM-76 underscores the unmet need in platinum-resistant ovarian cancer.

Nuvalent has submitted an NDA to the FDA for neladalkib, a brain-penetrant ALK-selective TKI for pretreated advanced ALK-positive NSCLC.

FDA grants orphan drug designation to rhenium (186Re) obisbemeda for pediatric glioma and ependymoma, supported by the phase 1/2a ReSPECT-PBC clinical trial.

The FDA has granted fast track and rolling review status to Celltrion’s CT-P71, a Nectin-4 targeting ADC for treating advanced urothelial carcinoma.

Tovecimig plus paclitaxel lifts response rates in second-line biliary tract cancer, prompting FDA orphan status and advancing a potential new option.

FDA grants fast track designation to SIM0505, a CDH6-targeting ADC, for platinum-resistant ovarian cancer. Phase 1 data expected at ASCO 2026.

The FDA did not grant accelerated approval to the oncolytic virus-based therapy RP1 in combination with nivolumab for patients with advanced melanoma.

FDA accepted the NDA for 18F-FET, a PET imaging agent designed to distinguish glioma progression from treatment-induced changes in brain cancer.

FDA grants priority review to ifinatamab deruxtecan for extensive-stage SCLC based on phase 2 IDEATE-Lung01 data. PDUFA date set for October 10, 2026.

The FDA granted FTD to OPN-6602, an oral EP300/CBP inhibitor currently used in a first-in-human phase 1 trial.

FDA reviews new zenocutuzumab bid for NRG1 fusion cholangiocarcinoma and NCCN adds new recommendations for use of the bispecific antibody.

Enrollment restarts in a phase 2 ovarian and clear cell gynecologic cancer study after FDA lifts hold on PD-1/CTLA-4 DART therapy.

ODD status was granted based on tumor response rates with eftilagimod alfa and pembrolizumab of more than 3-fold above historical benchmarks from radiotherapy alone.

BBO-11818 has received FDA fast track designation for KRAS-mutant pancreatic cancer, with early phase 1 data showing antitumor activity.

The target date for the FDA's decision on isatuximab via on-body injector is now July 23, 2026.

The FDA has has granted a priority review to zanidatamab-based regimens for the first-line treatment of patients with gastroesophageal adenocarcinoma.

FDA accepted the NDA for zipalertinib to treat previously treated metastatic NSCLC with EGFR exon 20 insertion mutations. Target action date: 2/27/27.

The DNA ImmunoBody therapy improved efficacy when added to ipilimumab and nivolumab, with a registrational phase 3 trial expected to begin later this year.

FDA designates TERN-701 as breakthrough therapy for heavily pretreated Ph+ CP-CML, as allosteric BCR-ABL inhibitor shows rapid deep molecular responses and tolerable safety.

The oral gamma secretase inhibitor varegacestat improved progression-free survival and overall response rate vs placebo; full results to be presented at ASCO.

The FDA's ODAC voted 6-3 against camizestrant for HR+/HER2– breast cancer, citing concerns over the SERENA-6 trial design and a lack of overall survival data.

The FDA's Oncologic Drugs Advisory Committee voted in favor 7 to 1 that benefits of capivasertib outweighed risks.