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Aug 20, 2026
The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
Aug 05, 2026
The FDA granted Fast Track designation to Oncolytics Biotech's pelareorep combined with a checkpoint inhibitor for advanced squamous cell carcinoma of the anal canal. The designation follows encouraging GOBLET study data and supports development in an estimated $1 billion market with no approved therapies.
Jul 21, 2026
FDA approved zenocutuzumab-zbco (Bizengri) for NRG1 fusion-positive cholangiocarcinoma on May 8, 2026. The eNRGy trial showed a 36.8% ORR. It also received priority review, breakthrough, and orphan designations.
Aug 06, 2026
Cocrystal Pharma advanced CDI-988 in a Phase 1b norovirus study and received FDA Fast Track designation. Nuvation Bio reported $18.5 million in IBTROZI net product revenues and presented updated TRUST trial data. Nautilus Biotechnology progressed its proteomics platform toward commercialization, maintaining a cash runway through 2027.
Jul 20, 2026
The FDA has cleared Telomir Pharmaceuticals' IND for Telomir-Zn in advanced or metastatic triple-negative breast cancer. The company plans to initiate a first-in-human Phase 1/2 trial in the first half of 2026.
Jun 02, 2026
Multiple oncology trials present recent results, including cabozantinib-nivolumab activity in non-clear cell RCC, savolitinib efficacy in MET-amplified gastric cancer, and induction nivolumab feasibility in HPV-driven oropharyngeal cancer.
May 27, 2026
Three trials show ultra-low-dose checkpoint inhibitors retain efficacy with reduced toxicity and dramatically lower costs. DELII and Patil et al. trials tested low-dose nivolumab in solid tumors and HNSCC; NIVIPIT tested intratumoral low-dose ipilimumab in melanoma.
May 22, 2026
FDA approves AstraZeneca and Daiichi Sankyo's Datroway for first-line TNBC patients not eligible for PD-1/L1 inhibitors, based on Phase III TROPION-Breast02 data showing a 21% reduction in risk of death versus chemotherapy.
May 19, 2026
An interim phase 3 analysis showed mezigdomide plus carfilzomib and dexamethasone reduced the risk of progression or death in relapsed/refractory multiple myeloma. The SUCCESSOR-2 study remains ongoing and will assess overall survival and safety.
May 18, 2026
The FDA approved Bristol Myers Squibb’s Breyanzi for adults with relapsed or refractory marginal zone lymphoma after at least two prior systemic therapies. In TRANSCEND FL, the CAR T therapy showed a 95.5% overall response rate and 62.1% complete response rate.
May 14, 2026
The FDA approved oral decitabine and cedazuridine tablets plus venetoclax for newly diagnosed AML in patients 75 and older or those ineligible for intensive induction chemotherapy. The approval was supported by phase 1/2 ASTX727-07 data showing a 41.6% complete response rate.
May 13, 2026
Tumour-infiltrating lymphocyte therapy has shown durable responses in refractory melanoma, including a 31.4% objective response rate in phase II data. The 2024 FDA approval of Lifileucel marked a milestone as regulators in other markets continue reviews.
May 11, 2026
The FDA has accepted for review a supplemental application for taletrectinib in advanced ROS1-positive NSCLC, with a PDUFA date of January 4, 2027. Updated TRUST-I and TRUST-2 data showed high response rates, durable responses and no new safety signals.
May 01, 2026
Crescent Biopharma dosed the first patient in its ASCEND Phase 1/2 trial of CR-001, a PD-1 x VEGF bispecific antibody for solid tumors. The company also reported Q1 2026 results and outlined pipeline milestones including ADC combination trials expected in the second half of 2026.
Apr 20, 2026
Phase III data showed dirozalkib improved progression-free survival and intracranial efficacy versus crizotinib in first-line ALK-positive advanced NSCLC. The drug received NMPA approval in August 2025.
Apr 19, 2026
Tango Therapeutics said it plans to start a pivotal 300-patient randomized vopimetostat trial in second-line pancreatic cancer this year after FDA interactions. The company also reported early combination enrollment with daraxonrasib and zoldonrasib and said more monotherapy and combination data are expected later this year.
Apr 17, 2026
Early results from stage I of the phase 3 PRESERVE-003 trial showed gotistobart improved overall survival versus docetaxel in previously treated metastatic squamous NSCLC. Objective response rate and duration of response also favored gotistobart, while progression-free survival did not differ significantly.
Apr 16, 2026
The FDA approved once-monthly subcutaneous amivantamab with lazertinib for first-line EGFR-mutated advanced NSCLC. PALOMA-2 showed high response rates and no new safety signals.
Apr 11, 2026
Cabozantinib plus metronomic temozolomide showed a 15% response rate and 28.5-month median progression-free survival in a phase 2 NET study. A separate analysis found cabozantinib cost-effective for pancreatic NETs, but not extrapancreatic NETs, in China and the U.S.
Apr 08, 2026
ALX Oncology has multiple 2026 catalysts for Evorpacept and ALX2004. Interim ASPEN-09 data are expected in Q3 2026, while an initial safety update from the phase 1 ALX2004 trial is expected in 1H 2026.
