October 2026 FDA Approvals: 7 Cancer Updates for Oncology Nurses

In October 2026, the FDA approved or expanded 7 cancer therapies spanning chronic lymphocytic leukemia, HER2-positive breast cancer, colon and rectal cancer, bladder cancer, prostate cancer, and tumor mutational burden–high (TMB-H) solid tumors. Most of the new indications depend on a biomarker test, and several move treatment into earlier settings. The accompanying video covers all 7 in under 3 minutes; the list below summarizes each approval and its key nursing considerations.

What did the FDA approve in October 2026?

1. Pirtobrutinib (Jaypirca) in untreated CLL/SLL

On October 2, the indication for the non-covalent BTK inhibitor expanded to adults with previously untreated CLL/SLL with no known 17p deletion. In BRUIN CLL-313, pirtobrutinib reduced the risk of progression or death by 80% compared with bendamustine plus rituximab (HR, 0.20).¹ Baseline and ongoing complete blood counts and liver function tests are required, along with monitoring for infection, bleeding, and atrial fibrillation.

2. Tucatinib (Tukysa) maintenance in HER2-positive breast cancer

Approved October 7 with trastuzumab and pertuzumab after 4 to 8 cycles of induction therapy, tucatinib extended median progression-free survival to 24.9 months vs 16.3 months with placebo in HER2CLIMB-05.² The label carries a boxed warning for hepatotoxicity, and a diarrhea management plan should be in place before the first dose.

3. Atezolizumab (Tecentriq) in stage 3 dMMR colon cancer

On October 8, the FDA approved atezolizumab with fluoropyrimidine and oxaliplatin chemotherapy as adjuvant treatment, along with a subcutaneous formulation (Tecentriq Hybreza). In ATOMIC, the combination halved the risk of recurrence or death (HR, 0.50).³ Treatment lasts about 12 months, and grade 3 to 4 neutropenia occurred in 43.6% of patients.

4. Nogapendekin alfa inbakicept-pmln (Anktiva) in papillary-only NMIBC

The October 14 expansion covers BCG-unresponsive, high-grade non-muscle invasive bladder cancer with papillary-only tumors, based on extrapolation from carcinoma in situ efficacy data.⁴ The regimen is given with BCG and can extend to 37 months of instillations. Dysuria, hematuria, urinary tract infection, chills, and pyrexia were among the most common reactions.

5. Pembrolizumab (Keytruda) in TMB-H solid tumors

On October 16, the 2020 accelerated approval became a traditional approval for the IV and subcutaneous (Keytruda Qlex) formulations, and the TMB-H cutoff rose from 10 to 13 mutations per megabase (mut/Mb).⁵ Patients with earlier results of 10 to less than 13 mut/Mb now fall outside the label. The objective response rate was 36% among 220 patients.

6. Dostarlimab (Jemperli) in dMMR rectal cancer

Dostarlimab received accelerated approval on October 19 for stage II/III MSI-H/dMMR locally advanced rectal cancer. In AZUR-1, 71% of 154 patients received dostarlimab alone with no additional treatment and no disease progression.⁶ Patients managed without surgery were assessed every 4 months for 2 years, then every 6 months.

7. Talazoparib (Talzenna) plus enzalutamide in HRR-mutated mCSPC

Approved October 26, the combination reduced the risk of radiographic progression or death by 52% in TALAPRO-3 (HR, 0.48); overall survival data were immature.⁷ Anemia occurred in 71% of patients, and 40% required a transfusion.

What are the key takeaways for oncology nurses?

• Confirm the required biomarker (17p deletion, HER2, dMMR/MSI-H, TMB of at least 13 mut/Mb, or HRR status) before treatment planning.^1-3,5-7
• Distinguish the 2 dMMR approvals: atezolizumab is adjuvant therapy with chemotherapy in colon cancer, whereas dostarlimab is given alone in rectal cancer and may allow responders to avoid surgery.^3,6
• Plan laboratory monitoring for anemia, neutropenia, and liver toxicity, and build patient education around longer treatment courses and surveillance schedules.^1-3,7

References

1. FDA approves pirtobrutinib for untreated CLL/SLL. Oncology Nursing News. October 2, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-approves-pirtobrutinib-for-untreated-cll-sll
2. FDA approves maintenance tucatinib for advanced HER2+ breast cancer. Oncology Nursing News. October 7, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-approves-maintenance-tucatinib-for-advanced-her2-breast-cancer
3. FDA approves atezolizumab plus chemo for stage 3 dMMR colon cancer. Oncology Nursing News. October 8, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-approves-atezolizumab-plus-chemo-for-stage-3-dmmr-colon-cancer
4. FDA expands Anktiva approval to papillary-only BCG-unresponsive NMIBC. Oncology Nursing News. October 14, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-expands-anktiva-approval-to-papillary-only-bcg-unresponsive-nmibc
5. FDA grants traditional approval to pembrolizumab in TMB-H solid tumors. Oncology Nursing News. October 22, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-grants-traditional-approval-to-pembrolizumab-in-tmb-h-solid-tumors
6. FDA grants accelerated approval to dostarlimab in dMMR rectal cancer. Oncology Nursing News. October 19, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-grants-accelerated-approval-to-dostarlimab-in-dmmr-rectal-cancer
7. FDA approves talazoparib plus enzalutamide in HRR-mutated mCSPC. Oncology Nursing News. October 26, 2026. Accessed October 26, 2026. https://www.oncnursingnews.com/view/fda-approves-talazoparib-plus-enzalutamide-in-hrr-mutated-mcspc