Five Solid Tumor Advances That Defined July 2026

July 2026 delivered a dense run of regulatory milestones across the solid tumor landscape, from a practice-changing perioperative regimen in bladder cancer to the first blood-based colorectal cancer (CRC) screening options reaching more patients. For pharmacists, the month underscored a broader shift toward biomarker-driven, tissue-agnostic, and lower-toxicity approaches to cancer care, each carrying implications for dispensing, monitoring, and patient counseling.

Here are 5 updates from the month that are worth knowing.

1. Pembrolizumab Plus Enfortumab Vedotin Expands to All Cystectomy-Eligible Muscle-Invasive Bladder Cancer

On July 10, 2026, the FDA broadened the perioperative approval of pembrolizumab (Keytruda; Merck)—including its subcutaneous formulation, pembrolizumab with berahyaluronidase alfa-pmph (Keytruda Qlex)—plus enfortumab vedotin-ejfv (Padcev; Astellas Pharma US, Inc, Seagen Inc) to all patients with muscle-invasive bladder cancer (MIBC) who are candidates for cystectomy, extending eligibility beyond the previously cisplatin-ineligible population.¹

The decision was anchored by the phase 3 KEYNOTE-B15 trial (NCT04700124), which randomly assigned 808 patients to perioperative pembrolizumab plus enfortumab vedotin or neoadjuvant gemcitabine plus cisplatin.¹

Enfortumab vedotin is an antibody-drug conjugate targeting Nectin-4, driving cell-cycle arrest and apoptosis. Grade 3 or higher adverse events (AEs) occurred in 75.7% of the combination arm, and pharmacists should counsel on immune-mediated reactions, peripheral neuropathy, skin reactions, and ocular disorders. With roughly half of patients with MIBC unable to tolerate cisplatin and about half experiencing recurrence after cystectomy, the expanded label addresses a substantial treatment gap.¹

2. Selpercatinib Earns Traditional, Tissue-Agnostic Approval for RET Fusion-Positive Solid Tumors

The FDA converted selpercatinib (Retevmo; Eli Lilly) to traditional approval on July 14, 2026, for locally advanced or metastatic RET fusion-positive solid tumors across cancer types in adult and pediatric patients aged 2 years and older—cementing its status as a tissue-agnostic option first cleared under accelerated approval in 2022.²

In the LIBRETTO-001 trial (NCT03157128), 75 patients with RET fusion-positive tumors outside of non–small cell lung cancer and thyroid cancer achieved an approximate 47% overall response rate with a median duration of response of 24.5 months, with activity spanning colorectal, pancreatic, cholangiocarcinoma, breast, ovarian, sarcoma, and neuroendocrine histologies. Pediatric support came from LIBRETTO-121 (NCT03899792).²

As a highly selective RET kinase inhibitor with minimal off-target activity, selpercatinib is dosed by weight—120 mg twice daily for patients under 50 kg and 160 mg twice daily for those 50 kg or more. The conversion reinforces the value of broad next-generation sequencing to identify RET fusions regardless of tumor origin.²

3. Gedatolisib Combination Approved for PIK3CA Wild-Type HR+/HER2- Breast Cancer

On July 14, 2026, the FDA approved gedatolisib (Revtorpyk; Celcuity) with fulvestrant (Faslodex; AstraZeneca), with or without palbociclib (Ibrance; Pfizer), for hormone receptor-positive (HR+), HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation, following progression on at least one line of endocrine therapy in the metastatic setting.³

The phase 3 VIKTORIA-1 trial (NCT05501886) enrolled 392 patients. In the PIK3CA wild-type population, the gedatolisib triplet extended median progression-free survival to 9.3 months compared with 2.0 months with fulvestrant alone—a 76% reduction in risk (HR, 0.24)—while the doublet reached 7.4 months (HR, 0.33). Objective response rates were 32% and 28% versus just 1% for control.³

Gedatolisib is notable as the first approved multitarget inhibitor of all class I PI3K isoforms plus mTORC1/2, a design intended to blunt the compensatory signaling that drives endocrine resistance. Investigators referred to it as "one of the most significant advances this year" for HR+/HER2- advanced breast cancer. The approval also expands treatment for the PIK3CA wild-type population, which has historically had fewer targeted options than PIK3CA-mutated disease.³

4. Zidesamtinib Approved for Previously Treated ROS1-Positive NSCLC

The FDA approved zidesamtinib (Jideytro; GSK) on July 22, 2026—nearly 2 months ahead of its September target date—for adults with locally advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 tyrosine kinase inhibitor (TKI). It marks GSK's first lung cancer approval and holds Breakthrough Therapy and Orphan Drug designations.⁴

In the ARROS-1 trial (NCT05118789), zidesamtinib produced an approximate 44% objective response rate among 117 evaluable patients, with 69% of responders maintaining a response at 12 months. Notably, the intracranial response rate reached 48% in patients with measurable CNS lesions—a key advantage given how often ROS1-positive NSCLC progresses in the brain.⁴

The next-generation, ROS1-selective TKI combines broad resistance-mutation coverage with blood-brain barrier penetration. The most common AEs (≥15%) include edema, peripheral neuropathy, constipation, fatigue, and dyspnea. As advocate Janet Freeman-Daily put it, "The goal is not just more time but quality time to live life as normally as possible while on treatment."⁴

5. SimpleScreen CRC Becomes a New Blood-Based Colorectal Cancer Screening Option

On July 27, 2026, the FDA approved SimpleScreen CRC, a blood-based methylation cell-free DNA assay for CRC screening in average-risk adults aged 45 and older referred by a health care provider. Abbott will exclusively commercialize the test in the US beginning Fall 2026.⁵

In the PREEMPT CRC (NCT04369053) study of more than 48,000 participants, the assay demonstrated an approximate 81.1% sensitivity and 90.4% specificity for CRC. The test correctly identified roughly 8 of 10 existing cancers and returning negative results for about 9 of 10 individuals without CRC or advanced precancerous lesions. Sensitivity for advanced precancerous lesions was lower, at 13.7%.⁵

A positive result signals the need for follow-up colonoscopy. Pharmacists can play a role in counseling patients that blood-based screening is a tool to improve adherence, particularly for those unwilling or unable to complete preferred methods—though the American Cancer Society continues to prioritize stool-based tests and visual examinations as first-line options.⁵

REFERENCES

1. McGovern G. Pembrolizumab Plus EV Regimens Receive FDA Approval for Muscle-Invasive Bladder Cancer. Pharmacy Times. July 10, 2026. Accessed July 31, 2026. https://www.pharmacytimes.com/view/pembrolizumab-plus-ev-regimens-receive-fda-approval-for-muscle-invasive-bladder-cancer

2. Valletti D. FDA Grants Traditional Approval to Selpercatinib for RET Fusion–Positive Solid Tumors Across Multiple Cancer Types. Pharmacy Times. July 14, 2026. Accessed July 31, 2026. https://www.pharmacytimes.com/view/fda-grants-traditional-approval-to-selpercatinib-for-ret-fusion-positive-solid-tumors-across-multiple-cancer-types

3. McGovern G. Gedatolisib Combination Approved for PIK3CA Wild-Type HR+, HER2– Breast Cancer. Pharmacy Times. July 14, 2026. Accessed July 31, 2026. https://www.pharmacytimes.com/view/gedatolisib-combination-approved-for-pik3ca-wild-type-hr-her2-breast-cancer

4. Ferruggia K. FDA Approves Zidesamtinib for Previously Treated ROS1-Positive NSCLC. Pharmacy Times. July 22, 2026. Accessed July 31, 2026. https://www.pharmacytimes.com/view/fda-approves-zidesamtinib-for-previously-treated-ros1-positive-nsclc

5. Valletti D. FDA Approves SimpleScreen CRC Blood Test for Colorectal Cancer Screening. Pharmacy Times. July 28, 2026. Accessed July 31, 2026. https://www.pharmacytimes.com/view/fda-approves-simplescreen-crc-blood-test-for-colorectal-cancer-screening