Every Oncologic FDA Approval Throughout August 2025

In August of 2025, the U.S. Food and Drug Administration (FDA) approved various anti-cancer treatments and therapeutic approaches across a range of disease types, such as colorectal, non-small cell lung cancer (NSCLC), and brain cancer.

Here is a list of cancer therapies approved by the regulatory agency over the last month.

FDA Approves Dako Omnis Test for Colorectal Cancer

The FDA has approved the mismatch repair immunohistochemical panel pharmDx (Dako Omnis) as a companion diagnostic test for colorectal cancer, according to a news release from Agilent Technologies.

The test helps identify patients with mismatch repair deficient colorectal cancer who may be eligible for treatment with Opdivo (nivolumab) alone or in combination with Yervoy (ipilimumab). It is the only FDA-approved immunohistochemistry panel designed to detect loss of function in any of the four mismatch repair proteins in preserved colorectal cancer tissue.

Deficiency in the mismatch repair pathway can lead to microsatellite instability and a higher tumor mutation burden, which may make cancers more likely to respond to immunotherapy. Between 5% and 15% of colorectal cancers have mismatch repair deficiency or microsatellite instability-high status. Detecting these features can help guide treatment decisions, screen for Lynch syndrome and identify patients who may experience more aggressive disease.

“This approval marks an important step forward in the ongoing effort to improve colorectal cancer care,” Nina Green, vice-president and general manager of Agilent’s Clinical Diagnostics Division, said. “Our new companion diagnostic product offers healthcare providers an additional tool to identify mismatch repair deficiency in patients, complementing existing options and enhancing the ability to tailor immunotherapy treatments. By providing more choices, we aim to support better tumor control and potentially improve progression-free survival, ultimately contributing to patient care and well-being.”

Agilent noted that this approval provides physicians with another tool to help tailor treatment strategies, ultimately supporting better tumor control and progression-free survival.

FDA Grants Accelerated Approval to Hernexeos for HER2-Mutated NSCLC

The FDA has granted accelerated approval to Hernexeos (zongertinib), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 tyrosine kinase domain (TKD) mutations and who have received prior treatment.

Approval was based on the Beamion LUNG-1 clinical trial, where patients who had previously received platinum-based chemotherapy achieved a 75% response rate with Hernexeos. Among those, 58% had a response lasting at least six months. In patients who had also received a HER2-targeting antibody-drug conjugate, the response rate was 44%, with 27% maintaining a response for at least six months.

Hernexeos has also shown durable responses and potential intracranial activity in patients with brain metastases. In earlier trial data, disease control was reported in 96% of patients, with a median progression-free survival of 12.4 months and a duration of response of 14.1 months.

According to the biopharmaceutical company Boehringer Ingelheim, Hernexeos may represent the first oral targeted therapy for HER2-mutated NSCLC, offering a new option for patients who previously had limited targeted treatment approaches.

FDA Approves Modeyso for Rare Pediatric and Adult Brain Cancer

The FDA has granted accelerated approval to Modeyso (dordaviprone) for the treatment of adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation that has progressed after prior therapy. Modeyso is the first FDA-approved systemic therapy for this rare and aggressive brain cancer.

Efficacy was evaluated in 50 patients treated in five clinical trials. The overall response rate was 22%, with responses lasting a median of 10.3 months. Among those who responded, 73% maintained a response for at least six months and 27% for at least one year.

Modeyso was generally well tolerated, with fatigue being the most common side effect. Severe (grade 3) treatment-related side effects occurred in approximately 20% of patients, though no life-threatening events or treatment-related deaths were reported.

Chimerix, the company developing Modeyso, emphasized that this approval marks a significant milestone for patients with few treatment options beyond palliative care. Modeyso also holds fast-track and orphan drug designation in the United States, Europe and Australia.

Reference

1. Agilent MMR IHC Panel pharmDx (Dako Omnis) Receives FDA Approval as a Companion Diagnostic Test for Colorectal Cancer,” by Agilent Technologies. News Release; Aug. 20, 2025.
2. “FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations,” by the U.S. FDA. News release; Aug. 8, 2025.
3. “FDA grants accelerated approval to dordaviprone for diffuse midline glioma,” by the U.S. FDA. News release. Aug. 6., 2025.

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