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May 20, 2026
ImmunityBio said the FDA accepted its sBLA for ANKTIVA plus BCG in BCG-unresponsive non-muscle invasive bladder cancer with papillary disease. The PDUFA date is Jan. 6, 2027.
May 17, 2026
ImmunityBio said the Saudi FDA encouraged submission of a regulatory package for recombinant BCG and opened talks on expanding ANKTIVA with checkpoint inhibitors to additional tumor types. The company expects to file the rBCG package within weeks.
May 16, 2026
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
Apr 25, 2026
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
Apr 22, 2026
A study in Cell suggests a urine DNA test may help identify which people with non-muscle invasive bladder cancer are likely to benefit from BCG immunotherapy. The test detected minimal residual disease after surgery and BCG treatment and distinguished recurrence risk based on tumour DNA findings.
Apr 14, 2026
Samsung Bioepis plans to start a global Phase 1 trial of SBE303, its first independently developed new drug candidate targeting Nectin-4. Preclinical data showed tolerability up to 40 mg/kg in monkeys.
Apr 10, 2026
Durvalumab has been approved for rollout on the NHS for muscle-invasive bladder cancer. In a trial of more than 1,000 patients, it cut the risk of progression by 32% versus standard care.
Mar 30, 2026
The National Comprehensive Cancer Network has updated its bladder cancer guidelines to include ImmunityBio's Anktiva plus BCG for BCG-unresponsive papillary-only disease. The Category 2A recommendation expands treatment options beyond the drug's initial FDA approval for carcinoma in situ. ImmunityBio also announced its pivotal trial is adequately powered and European distribution partnerships to expand global access.
Mar 29, 2026
The phase 3 ENVISION trial shows 80% complete response rate for novel bladder cancer chemoablative therapy. AI integration accelerates precision oncology through biomarker identification and targeted treatments. OncoPRO real-time symptom monitoring system enhances patient safety and clinical trial data capture.
Mar 26, 2026
Merck will acquire Terns Pharmaceuticals for $6.7 billion to bolster its cancer pipeline ahead of Keytruda's 2028 patent expiration. The deal gives Merck access to TERN-701, an oral tyrosine kinase inhibitor for chronic myeloid leukemia. Merck projects over $70 billion in commercial opportunities from its pipeline by the mid-2030s.
Mar 12, 2026
Pembrolizumab-based regimens demonstrated significant survival improvements in two separate trials: KEYNOTE-B15 for muscle-invasive bladder cancer and KEYNOTE-B96 for platinum-resistant ovarian cancer, with FDA approval granted for the ovarian cancer indication.
Mar 04, 2026
The immuno-oncology market is projected to grow from $65.22 billion in 2025 to $170.19 billion by 2032, driven by checkpoint inhibitors, CAR-T cell therapy, and cancer vaccines, with North America commanding 43% market share.
Mar 02, 2026
Merck is diversifying its oncology pipeline beyond Keytruda as the blockbuster approaches patent cliffs, focusing on immune modulating therapies, antibody-drug conjugates, and tumor intrinsic treatments through strategic acquisitions and partnerships.
Mar 02, 2026
Genmab is moving GEN1106, a SLITRK6-targeting ADC acquired through its $1.8bn ProfoundBio takeover, into phase 1 trials despite several recent discontinuations and the 2017 failure of the only other similar project.
Feb 27, 2026
ImmunityBio completed enrollment of 366 patients in its Phase 2 trial of ANKTIVA plus BCG versus BCG alone for BCG-naïve bladder cancer. Interim analysis showed statistically significant improvement in duration of complete response, with the company anticipating a BLA submission by Q4 2026.
Feb 27, 2026
New research shows cancer survivors who exercise reduce their risk of cancer-related death, while expert panel recommends exercise as essential for older cancer patients during and after treatment.
Feb 21, 2026
ImmunityBio receives conditional EU marketing authorization for Anktiva combination therapy in bladder cancer, covering 33 countries, while establishing distribution partnerships in Saudi Arabia for bladder and lung cancer patients.
Feb 19, 2026
A comprehensive market report reveals over 180 companies are developing more than 200 PD-1 and PD-L1 inhibitor drugs, with recent fast-track designations and successful Phase III trial results driving expansion in cancer immunotherapy.
Feb 25, 2026
Ultrasensitive testing of tumor DNA in blood and urine may identify muscle-invasive bladder cancer patients who can safely forgo radical cystectomy, with 69% achieving 3-year bladder-intact survival after systemic therapy.
Feb 24, 2026
ImmunityBio announced $113 million in net product revenue for Anktiva in 2025, a 700% year-over-year increase, while expanding regulatory authorization to 33 countries and securing first approval for lung cancer treatment in Saudi Arabia.
