Oncology
Anktiva Expands for Papillary-Only Bladder Cancer
The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive, high-grade papillary non-muscle-invasive bladder cancer without carcinoma in situ.
Rayan Salih · November 13, 2026 · 6 min
Cancer care and research
Oncology
Practice-changing oncology and hematology research, from early detection through survivorship.
Oncology
Atezolizumab Approved for Stage III dMMR Colon Cancer
The FDA approved adjuvant atezolizumab plus chemotherapy after resection of stage III dMMR colon cancer in adults and patients aged 12 years or older. The subcutaneous formulation is limited to adults.
Rayan Salih · 6 min read
Oncology
Pembrolizumab Gains Traditional Approval in TMB-High Tumors
The FDA action covers adults and children with unresectable or metastatic solid tumors measuring at least 13 mutations/Mb after prior progression when satisfactory alternatives are unavailable.
Rayan Salih · 7 min read
Oncology
Prostate Cancer Approval Expands Talazoparib Eligibility
The FDA has expanded talazoparib plus enzalutamide to selected adults with HRR-mutated metastatic castration-sensitive prostate cancer. Treatment requires mutation confirmation with an FDA-authorized test.
Rayan Salih · 7 min read
Oncology
Dostarlimab Gains Accelerated Approval in Rectal Cancer
The indication covers adults with stage II or III locally advanced rectal cancer that is MSI-H or dMMR, as established with an FDA-authorized test.
Rayan Salih · 6 min read
Oncology
Prostate Cancer: HRR Testing Defines Talazoparib Use
The verified FDA indication covers adults with HRR gene-mutated metastatic castration-resistant prostate cancer, making an approved companion diagnostic essential before talazoparib plus enzalutamide.
Dr. Abu Bakar · 6 min read
Oncology
Talazoparib Plus Enzalutamide for HRR-Mutated Prostate Cancer
The FDA approved talazoparib plus enzalutamide for adults with HRR-mutated metastatic prostate cancer that remains naïve or sensitive to androgen-pathway modulation. An FDA-authorized test must confirm eligibility.
Dr. Abu Bakar · 7 min read
Oncology
Dostarlimab Reframes Organ Preservation in Rectal Cancer
Accelerated approval adds dostarlimab as an initial option for selected patients with untreated stage II or III MSI-H or dMMR rectal cancer, making organ preservation an early multidisciplinary decision.
Rayan Salih · 6 min read
Oncology
Pirtobrutinib Enters First-Line CLL and SLL Treatment
The FDA has moved pirtobrutinib into previously untreated CLL and SLL, expanding first-line choice when therapy is indicated rather than reserving the drug for later lines.
Rayan Salih · 6 min read
Oncology
Dostarlimab Offers Treatment-Only Path in Rectal Cancer
Accelerated approval makes dostarlimab an initial option for previously untreated stage II or III MSI-H/dMMR rectal cancer, with the possibility of avoiding chemotherapy, radiation and surgery.
Rayan Salih · 6 min read
Oncology
Pembrolizumab Resets TMB-High Threshold to 13 Mut/Mb
FDA traditional approval defines TMB-high solid tumors as at least 13 mutations per megabase. Eligibility depends on confirming that the reported result meets the new cutoff.
Rayan Salih · 7 min read
Oncology
FDA Approves Lirafugratinib for FGFR2-Altered Cholangiocarcinoma
The FDA approved lirafugratinib for previously treated cholangiocarcinoma with an FGFR2 fusion or other rearrangement, adding a biomarker-defined option after earlier therapy.
Dr. Abu Bakar · 6 min read
Oncology
Edotreotide Improves PFS in GEP Neuroendocrine Tumors
In a phase 3 head-to-head trial, [177Lu]Lu-edotreotide extended progression-free survival compared with everolimus in progressive, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.
Rayan Salih · 6 min read
Oncology
Sevabertinib Makes HER2 Testing Pivotal in NSCLC
The FDA’s accelerated approval covers previously treated adults with advanced nonsquamous NSCLC harboring activating HER2 tyrosine-kinase-domain mutations detected by an approved test.
Rayan Salih · 6 min read
Oncology
FDA Expands Anktiva Plus BCG Approval to Papillary-Only Bladder Cancer
The FDA expanded Anktiva plus BCG to adults with BCG-unresponsive, high-grade papillary-only non–muscle-invasive bladder cancer, adding a bladder-preserving option for this underserved group.
Dr. Abu Bakar · 7 min read
Oncology
Dostarlimab Opens Treatment-Only Path in Rectal Cancer
FDA accelerated approval covers selected previously untreated adults with MSI-H or dMMR locally advanced rectal cancer, allowing standard chemoradiation and surgery to be deferred when a complete clinical response is sustained.
Rayan Salih · 7 min read
Oncology
Rectal Cancer: Who Fits the Dostarlimab Approval
The FDA approval applies to adults with untreated stage II or III locally advanced rectal cancer whose tumors are MSI-H or dMMR. Testing must occur before the initial treatment strategy is fixed.
Rayan Salih · 6 min read
Oncology
Atezolizumab Approved for Stage III dMMR Colon Cancer
The FDA approved atezolizumab plus fluoropyrimidine- and oxaliplatin-based chemotherapy after surgery for stage III mismatch-repair-deficient colon cancer.
Rayan Salih · 7 min read
Oncology
Atezolizumab Approved for Stage III dMMR Colon Cancer
The FDA approved adjuvant atezolizumab plus chemotherapy for adults and patients aged 12 years or older with resected stage III mismatch-repair-deficient colon cancer.
Rayan Salih · 6 min read
Oncology
FDA Approves Atezolizumab for Stage III dMMR Colon Cancer
The FDA approved adjuvant atezolizumab plus chemotherapy for adults and children aged 12 years and older with resected stage III mismatch-repair-deficient colon cancer.
Rayan Salih · 7 min read
Oncology
Cyclophosphamide Recall Prompts Inventory, Exposure Review
Three cyclophosphamide injection lots were recalled nationwide after steel particulate matter was found. Oncology teams need to trace inventory and review possible patient exposure.
Rayan Salih · 6 min read
Oncology
Sevabertinib Approved for HER2-Mutant Nonsquamous NSCLC
Accelerated approval covers previously treated advanced nonsquamous NSCLC with qualifying HER2 tyrosine-kinase-domain activating mutations confirmed by an FDA-approved test.
Rayan Salih · 6 min read
Oncology
Lirafugratinib Expands FGFR2 Cholangiocarcinoma Options
The FDA approved lirafugratinib for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma harboring an eligible FGFR2 fusion or rearrangement.
Rayan Salih · 7 min read
Oncology
Sevabertinib Approved for Advanced Non-Squamous NSCLC
The FDA granted accelerated approval to sevabertinib for a biomarker-defined group of adults with locally advanced or metastatic non-squamous NSCLC. The exact label governs testing and treatment-line eligibility.
Rayan Salih · 7 min read
Oncology
Gastric Cancer EFS Improves With Perioperative Serplulimab
ASTRUM-006 found an event-free survival benefit from adding serplulimab to perioperative SOX in PD-L1-positive, resectable gastric or gastroesophageal junction adenocarcinoma.
Rayan Salih · 7 min read
Oncology
ESR1-Mutated Breast Cancer Gains Imlunestrant Combination
The FDA approved imlunestrant plus abemaciclib for adults with ESR1-mutated, ER-positive, HER2-negative advanced or metastatic breast cancer after endocrine therapy progression.
Rayan Salih · 6 min read
Oncology
Sevabertinib Makes HER2 Testing Actionable in NSCLC
FDA accelerated approval makes tumor HER2 kinase-domain mutation status treatment-defining for eligible adults with previously treated, advanced nonsquamous NSCLC.
Rayan Salih · 7 min read
Oncology
Durvalumab Plus FLOT Improves Resectable Gastric Cancer
MATTERHORN found better event-free survival and pathologic response with perioperative durvalumab plus FLOT for resectable gastric or gastroesophageal junction adenocarcinoma.
Rayan Salih · 7 min read
Oncology
Sacituzumab Tirumotecan Improves PFS in Advanced NSCLC
Interim phase 3 results favor adding sacituzumab tirumotecan to first-line pembrolizumab for PD-L1-positive advanced NSCLC, but survival, safety and generalizability remain unsettled.
Rayan Salih · 6 min read
Oncology
Sevabertinib Approval Narrows HER2-Mutated NSCLC Use
FDA accelerated approval applies to previously treated, advanced non-squamous NSCLC with qualifying activating mutations in the HER2 tyrosine kinase domain—not every ERBB2 alteration.
Rayan Salih · 6 min read
Oncology
Treg Therapy Enters Matched-Donor Stem Cell Transplant
The FDA approved an allogeneic regulatory T-cell therapy for adults with hematologic malignancies undergoing matched-donor stem cell transplantation. Programs must assess eligibility, logistics and safety readiness.
Rayan Salih · 6 min read
Oncology
Ivonescimab Extends Survival in EGFR-Variant NSCLC
Ivonescimab plus chemotherapy prolonged median overall survival after EGFR-TKI therapy, but toxicity, generalizability and US regulatory status shape its relevance.
Rayan Salih · 7 min read
Oncology
Sevabertinib Makes HER2 Testing Actionable in NSCLC
The FDA granted accelerated approval to sevabertinib for adults with advanced nonsquamous NSCLC harboring activating HER2 tyrosine kinase domain mutations, making validated genomic identification central to treatment selection.
Rayan Salih · 6 min read
Oncology
Zidesamtinib Offers a Post-TKI Option in ROS1 NSCLC
Accelerated approval places zidesamtinib after a prior ROS1 tyrosine kinase inhibitor, with reported activity in systemic and intracranial disease but no randomized evidence yet.
Rayan Salih · 6 min read
Oncology
FDA Approves Rusfertide (Mimrylo) for Polycythemia Vera: A New Option for Erythrocytosis
FDA approval of rusfertide creates a systemic option for adults with polycythemia vera whose erythrocytosis has traditionally required phlebotomy, with or without cytoreductive therapy.
Dr. Abu Bakar · 6 min read
Oncology
FDA Approval of Vepdegestrant: A New ESR1-Targeted Option for Advanced Breast Cancer
FDA approval makes vepdegestrant an option for adults with ESR1-mutated, ER-positive, HER2-negative advanced breast cancer after prior endocrine therapy.
Dr. Abu Bakar · 6 min read
Oncology
Daraxonrasib Adds a Metastatic Pancreatic Cancer Option
The FDA approved daraxonrasib for adults with metastatic pancreatic adenocarcinoma after systemic therapy or when multi-agent therapy is not feasible.
Rayan Salih · 6 min read
Oncology
Gedatolisib Approved for PIK3CA-Wild-Type Breast Cancer
The FDA approved gedatolisib plus fulvestrant, with or without palbociclib, after endocrine therapy progression in PIK3CA-wild-type HR-positive, HER2-negative advanced breast cancer.
Rayan Salih · 6 min read
Oncology
Ivonescimab Improves Survival in Squamous NSCLC Trial
In China’s phase 3 HARMONi-6 trial, ivonescimab plus chemotherapy improved interim overall survival versus tislelizumab plus chemotherapy in advanced squamous NSCLC.
Rayan Salih · 6 min read
Oncology
Adjuvant CDK4/6 Benefits Diverge in Early Breast Cancer
A meta-analysis found invasive disease-free survival gains with adjuvant abemaciclib and ribociclib, but not palbociclib, in HR-positive, HER2-negative early breast cancer.
Rayan Salih · 7 min read
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