The FDA approved blinatumomab (Blincyto) for the consolidation phase of treatment in adults and children (1 month and older) with CD19-positive, Philadelphia-chromosome-negative B-cell precursor acute lymphoblastic leukemia (BCP-ALL), regardless of measurable residual disease (MRD) status — expanding its prior approvals, which were limited to MRD-positive or relapsed/refractory disease. The approval was supported primarily by the phase 3 ECOG-ACRIN E1910 trial (ClinicalTrials.gov NCT02003222; primary publication DOI 10.1056/NEJMoa2312948), an international, randomized study of 224 adults 30-70 years old in MRD-negative remission after induction/intensification chemotherapy, randomized to consolidation chemotherapy with or without blinatumomab. The trial reported significantly longer overall survival with blinatumomab added to chemotherapy.

The FDA granted accelerated approval to talquetamab-tgvs (Talvey), the first bispecific antibody directed at GPRC5D (a protein overexpressed on myeloma cells but with limited expression on normal blood cells), for adult patients with relapsed or refractory multiple myeloma who have already received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The approval was supported by the single-arm, open-label, phase 1/2 MonumenTAL-1 trial (ClinicalTrials.gov NCT04634552; primary publication in the New England Journal of Medicine, DOI 10.1056/NEJMoa2204591), which enrolled heavily pretreated patients across multiple dosing cohorts. Talquetamab works by simultaneously binding GPRC5D on myeloma cells and CD3 on the patient’s own T-cells, redirecting those T-cells to attack the cancer.

The FDA granted accelerated approval to epcoritamab-bysp (Epkinly), a subcutaneously-injected CD3xCD20 bispecific antibody, for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified — including DLBCL arising from an indolent lymphoma — and high-grade B-cell lymphoma, after two or more prior lines of systemic therapy. Epcoritamab works by simultaneously binding CD20 on lymphoma cells and CD3 on the patient’s own T-cells, physically bringing them together so the T-cells attack the cancer cells directly, without requiring the weeks-long individualized manufacturing process CAR T-cell therapies need. The approval was supported by the dose-expansion cohort of the open-label, single-arm, phase 1/2 EPCORE NHL-1 trial (ClinicalTrials.gov NCT03625037; primary publication in the Journal of Clinical Oncology, DOI 10.1200/JCO.22.01725, PMID 36548927), which enrolled 157 patients with relapsed or refractory large B-cell lymphoma and reported an objective response rate of 63.1%, including a 38.9% complete response rate. The prescribing information carries a boxed warning for cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome (ICANS), both known risks of this drug class.

The FDA granted full (traditional) approval to tarlatamab-dlle (Imdelltra), a DLL3xCD3 bispecific T-cell-engaging antibody, for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed on or after platinum-based chemotherapy — converting the drug’s original May 2024 accelerated approval into a full approval on the strength of a randomized, confirmatory trial. The conversion was supported by the randomized, open-label, phase 3 DeLLphi-304 trial (ClinicalTrials.gov NCT05740566), which enrolled 509 patients with ES-SCLC who had progressed on platinum-based chemotherapy (with or without an anti-PD-(L)1 agent). Overall survival — the trial’s primary endpoint — was significantly longer with tarlatamab: median 13.6 months versus 8.3 months with standard-of-care chemotherapy (hazard ratio 0.60, P<.001), a real, statistically significant survival benefit. Tarlatamab works by simultaneously binding DLL3 (a protein expressed on small cell lung cancer cells) and CD3 on the patient's own T-cells, directing those T-cells to attack the cancer.

The FDA approved pembrolizumab (Keytruda) for adults with resectable, locally advanced head and neck squamous cell carcinoma (HNSCC) whose tumors express PD-L1, to be given before surgery (neoadjuvant), then continued after surgery alongside radiotherapy (with or without chemotherapy), then as a single agent (adjuvant) — the first FDA approval for HNSCC in six years, and the first-ever perioperative (both before and after surgery) approval for locally advanced HNSCC. The approval was based on the randomized, open-label, phase 3 KEYNOTE-689 trial (ClinicalTrials.gov NCT03765918; primary publication in the New England Journal of Medicine, DOI 10.1056/NEJMoa2415434, PMID 40532178), which randomized 714 patients with stage III-IVA resectable HNSCC across 192 sites. Event-free survival — the trial’s primary endpoint — was significantly longer with pembrolizumab: median 51.8 months versus 30.4 months with standard of care alone, a statistically significant improvement. Adding pembrolizumab before surgery did not reduce the likelihood that surgery could be completed, and no new safety signals were identified.

The FDA approved pembrolizumab (Keytruda) in combination with paclitaxel, with or without bevacizumab, for adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who have received one to two prior lines of systemic therapy and whose tumors express PD-L1 (CPS >=1, per a companion diagnostic test) — the first immune checkpoint inhibitor regimen to demonstrate a statistically significant overall-survival benefit in a phase 3 ovarian cancer trial. The approval was based on the randomized, double-blind, phase 3 ENGOT-ov65/KEYNOTE-B96 trial (ClinicalTrials.gov NCT05116189; primary publication in The Lancet, DOI 10.1016/S0140-6736(26)00602-1, PMID 41974150), conducted at 187 gynaecologic oncology centres in 25 countries and enrolling 643 patients. Among PD-L1-positive participants, progression-free survival improved from 7.2 to 8.3 months (hazard ratio 0.72, P=.0014) and overall survival improved from 14.0 to 18.2 months (hazard ratio 0.76, P=.0053) with pembrolizumab added — real, statistically significant benefits on both endpoints.

An updated publication on dostarlimab in mismatch repair-deficient (dMMR) / microsatellite instability-high (MSI-H) rectal cancer reports sustained complete responses, studied as a nonoperative-management/organ-preservation approach. Updated primary publication: PMID 40293177, https://pubmed.ncbi.nlm.nih.gov/40293177/, DOI https://doi.org/10.1056/NEJMoa2404512. Trial registry: https://clinicaltrials.gov/study/NCT04165772. Earlier primary paper: PMID 35660797, https://pubmed.ncbi.nlm.nih.gov/35660797/. This result applies SPECIFICALLY to mismatch repair-deficient disease — it must never be generalized to rectal cancer broadly, and headline/summary language must not use unqualified phrasing implying the cancer ‘vanishes’ without the dMMR/MSI-H qualifier attached. [Identifiers as supplied, attributed to independent verification outside this environment — not independently re-verified live here.]

The FDA approved durvalumab (Imfinzi) as consolidation therapy for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease had not progressed after concurrent platinum-based chemotherapy and radiation — based on the randomized, placebo-controlled, phase 3 ADRIATIC trial (ClinicalTrials.gov NCT03703297; primary publication DOI 10.1056/NEJMoa2404873). ADRIATIC randomized 730 patients 1:1:1 to durvalumab monotherapy, durvalumab plus tremelimumab, or placebo; only the durvalumab-monotherapy arm is part of the FDA-approved regimen. Reported median overall survival was meaningfully longer with durvalumab than placebo, with a statistically significant reduction in risk of death, and progression-free survival was also significantly longer. Immune-mediated adverse events, including pneumonitis, occurred at a higher rate with durvalumab than placebo and are an important part of this drug class’s safety profile.

PT217 (peluntamig), an investigational bispecific antibody targeting DLL3 and CD47 developed by Phanes Therapeutics, is under study in the first-in-human, open-label, dose-escalation/dose-expansion SKYBRIDGE trial (ClinicalTrials.gov NCT05652686) in adults with advanced, DLL3-expressing neuroendocrine carcinomas — including small cell lung cancer, large cell neuroendocrine carcinoma of the lung, and extrapulmonary neuroendocrine carcinoma, a category that includes neuroendocrine prostate cancer. No peer-reviewed clinical results exist for PT217 as of this review — results are not yet available, and this record makes no treatment-effect claim of any kind. The sponsor, via its own press releases (not an FDA-published record), has stated that the FDA granted Fast Track Designation for two separate indications (extensive-stage small cell lung cancer, and metastatic neuroendocrine prostate cancer); this is presented here as a reported sponsor claim requiring direct regulatory corroboration before being treated as regulatory fact, not as a confirmed FDA action — and even if confirmed, this designation would expedite development and review, not constitute an approval or a claim that the drug works. This is deliberately a trial-status story, not a results story: it should never be described as effective, as working, or as a treatment option, since no such evidence currently exists in the public record. Fast Track designation claims here are sourced only to sponsor company press releases, since the FDA does not independently publish a searchable list of individual Fast Track grants — a genuine, structural sourcing limitation, not a specific red flag about this drug.