Also known as: plasma ctDNA
The FDA granted RMAT designation to Allogene’s cema-cel for first-line LBCL consolidation and Cellectis’ lasme-cel for r/r B-ALL. Both allogeneic CAR-T therapies showed promising early efficacy and safety, with cema-cel also receiving Fast Track status.
Recent prostate cancer research includes a Phase 2 trial of opaganib in advanced disease, a SEER study linking older age to higher mortality in bone-only metastases, and AI and genetic tools that improve detection.
The FDA extended the review deadline for AstraZeneca's camizestrant and issued a complete response letter for its COPD drug PT010. The agency also adopted a single-pivotal-trial approval policy, while AstraZeneca sold Losec rights to Cheplapharm.
The FDA approved Tecentriq and Tecentriq Hybreza for adjuvant muscle-invasive bladder cancer with ctDNA molecular residual disease after cystectomy. The Phase III IMvigor011 study showed a 36% reduction in recurrence or death and a 41% reduction in death.
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.
A Labcorp Drug Development medical director shared insights on MRD testing in lung cancer, breast cancer precision strategies, and cancer research for minority populations. She highlighted a Fox Chase Cancer Center collaboration for an ultra-sensitive MRD assay and discussed progress in ESR1 mutations and oral SERDs.
Two studies show liquid biopsy can predict immunotherapy response in HER2-negative breast cancer and identify which patients with relapsed germ cell tumors may benefit from high-dose chemotherapy, advancing precision oncology.
Studies in muscle-invasive bladder cancer found ctDNA predicted metastatic risk after bladder-sparing treatment, while urine tumor DNA was more sensitive for residual bladder disease. Data from RETAIN-2 and a PNAS study support molecular testing to help select patients for bladder preservation.
Allogene Therapeutics said it will present interim futility analysis data from the Phase 2 ALPHA3 trial of cema-cel in first-line consolidation LBCL on April 13, 2026. The readout will assess day-45 MRD clearance in 12 patients per arm randomized to cema-cel or observation.
Colorectal cancer diagnoses in people under 50 now account for nearly half of all new cases, prompting specialized treatment programs that use precision medicine and liquid biopsy technology to customize care based on individual tumor genetics.
