Therapies Which Received FDA Approval in July: What You Should Know

In June of 2025, the U.S. Food and Drug Administration (FDA) approved multiple cancer treatments and combination therapies across a range of indications, including lung and prostate cancers, as well as chronic lymphocytic leukemia.

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

FDA Approves Datroway for EGFR-Mutated Advanced Lung Cancer

The FDA has granted accelerated approval to Datroway (datopotamab deruxtecan‑dlnk) for adults with locally advanced or metastatic non‑small cell lung cancer (NSCLC) that carries an epidermal growth factor receptor (EGFR) mutation. This new option is intended for patients whose cancer has worsened after treatment with an EGFR‑targeted medicine and platinum‑based chemotherapy.

This decision was based on combined results from two studies — TROPION‑Lung05 and TROPION‑Lung01 — which enrolled 114 people with EGFR‑mutated NSCLC who had already received those prior therapies. When treated with the recommended dose of Datroway, approximately 45% of participants saw their tumors shrink or disappear (overall response rate), and this benefit lasted a median of 6.5 months.

“[Datroway] elicited promising [objective response rates], durable responses, and an acceptable safety profile in heavily pretreated patients with advanced NSCLC and actionable genomic alterations, including in the two predominant EGFR-mutation and ALK-rearrangement subgroups,” study authors wrote in findings published in the Journal of Clinical Oncology. “These findings suggest that this novel TROP2-directed [antibody-drug conjugate] may provide clinically meaningful benefit in a difficult-to-treat population with poor prognosis and lack of effective therapies.”

FDA Approves Illuccix to Guide Radioligand Use in Prostate Cancer

The FDA has expanded the approved use of Illuccix — a kit used to prepare gallium Ga‑68 gozetotide for injection — to help identify patients with metastatic castration-resistant prostate cancer who may benefit from radioligand therapy before starting chemotherapy. This update was announced on June 26th by Telix and applies to patients being considered for treatment prior to receiving taxane-based chemotherapy.

Illuccix is now approved to help determine which patients are eligible for prostate-specific membrane antigen (PSMA)–targeted therapies, based on the prescribing information of those treatments. This change follows the FDA’s decision to broaden the use of Pluvicto (lutetium Lu177 vipivotide tetraxetan) to men with metastatic castration-resistant prostate cancer who have already been treated with androgen receptor pathway inhibitors but have not yet received chemotherapy. Because Pluvicto can now be used earlier in treatment, the number of Illuccix scans is projected to rise by more than 20,000 each year.

“It is pleasing to see the ability to use gallium-68 PSMA-PET for patient selection expanded. This empowers clinicians to make more informed, personalized decisions earlier in the disease course and access life-prolonging targeted radionuclide therapy for more patients with prostate cancer," Dr. Scott T. Tagawa, a genitourinary oncologist at Weill Cornell Medicine and NewYork-Presbyterian, Weill Cornell Medical Center, said in the news release.

FDA Approves Monjuvi With Revlimid and Rituxan for Follicular Lymphoma

On June 18th, the FDA has approved the use of Monjuvi (tafasitamab‑cxix) in combination with Revlimid (lenalidomide) and Rituxan (rituximab) for adults with follicular lymphoma that has returned or not responded to prior treatment.

This approval is based on results from the inMIND clinical trial, which included 548 patients with relapsed or refractory disease. Participants were randomly assigned to receive either Monjuvi or a placebo, along with Revlimid and Rituxan. Most had previously received one line of therapy, though 25% had two prior treatments and 20% had three or more. The key outcome was how long patients lived without their cancer progressing.

After 14.1 months of follow-up, those treated with Monjuvi experienced a longer period without disease worsening — a median of 22.4 months — compared with 13.9 months in the placebo group.

“The inMIND phase 3 study met its primary end point of prolonging PFS in relapsed/refractory follicular lymphoma. Benefit was observed in all prespecified subgroups, including patients with POD24 [progression of disease within 24 months of initial diagnosis], [those who were] refractory to prior anti-CD20 monoclonal antibodies, and [those] receiving multiple prior lines of therapy," Dr. Laurie H. Sehn, lead study author and clinical professor of medicine at the University of British Columbia, in Vancouver, Canada, said in a presentation of the data.

FDA Approves Brukinsa Tablet For Various Blood Cancers

The FDA has approved a new tablet form of Brukinsa (zanubrutinib), making it available in this updated version for all five of its previously approved uses, according to a news release shared on June 11th.

Brukinsa is used to treat several types of blood cancer, including chronic lymphocytic leukemia, small lymphocytic lymphoma, Waldenström’s macroglobulinemia, and mantle cell lymphoma in patients who have already received at least one treatment. It is also approved for relapsed or refractory marginal zone lymphoma in individuals who were previously treated with an anti‑CD20 therapy, and for relapsed or refractory follicular lymphoma when combined with Gazyva (obinutuzumab) after two or more prior treatments.

“Brukinsa’s leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile,” Matt Shaulis, general manager of North America, BeOne, said in the news release. “With this new tablet formulation, we are making treatment simpler and more convenient — an important step forward for patients facing certain B-cell cancers.”

FDA Approves Perioperative Keytruda for Locally Advanced Head and Neck Cancer

On June 12th, the FDA has approved Keytruda (pembrolizumab) for adults with resectable, locally advanced head and neck squamous cell carcinoma that tests positive for PD-L1. Treatment involves Keytruda alone before surgery, followed by radiation — with or without cisplatin — after surgery, and then Keytruda again on its own.

This marks the first FDA approval for head and neck squamous cell carcinoma in six years and the first to cover treatment before and after surgery (perioperative use) for this type of cancer. Approval was based on the KEYNOTE-689 trial, which included 714 patients with resectable stage 3 or 4A disease.

Among the 682 patients with PD-L1–positive tumors, those who received Keytruda had a median event-free survival of 59.7 months compared to 29.6 months in the control group. Event-free survival measured the time until disease progression that prevented surgery, recurrence, spread, or death. Overall survival data are still being collected, but no safety concerns have been identified to date.

FDA Approves Ibtrozi for ROS1+ Advanced NSCLC

The FDA approved Ibtrozi (taletrectinib) on June 11th for adults with locally advanced or metastatic NSCLC that is positive for a ROS1 gene alteration.

This approval is based on results from two open-label clinical trials, TRUST-I and TRUST-II, which included patients with ROS1-positive NSCLC. In patients who had not received prior treatment, the overall response rate was 90% in TRUST-I and 85% in TRUST-II, with 72% and 63% of those patients, respectively, experiencing responses that lasted at least 12 months. Among patients who had previously been treated with a ROS1-targeted therapy, the response rate was 52% in TRUST-I and 62% in TRUST-II. In these groups, 74% and 83% of responders, respectively, maintained their response for at least 6 months.

FDA Approves Nubeqa in Metastatic Castration-Sensitive Prostate Cancer

The FDA has approved Nubeqa (darolutamide) for adults with metastatic castration-sensitive prostate cancer, as announced in an FDA news release on June 3rd.

This approval is based on findings from the phase 3 ARANOTE trial, which included 669 patients with this type of prostate cancer. Nubeqa significantly extended the time patients lived without their cancer worsening on imaging scans (radiographic progression-free survival) compared to those who received a placebo. The median rPFS was not reached in the Nubeqa group, while it was 25 months in the placebo group. No statistically significant difference in overall survival was observed at the final analysis. Reported side effects were consistent with what has been seen in previous studies, and the prescribing information includes warnings for ischemic heart disease, seizures, and embryo-fetal toxicity.

“When discussing treatment options with patients, it is important to consider efficacy, safety, and the impact of treatment on patients’ quality of life, and nurses play an important role in providing education to help patients manage disease symptoms and treatment side effects,” Brenda Martone, registered nurse and advanced practice provider, of Northwestern University, Feinberg School of Medicine in Chicago, and colleagues wrote in a poster. “The findings from ARANOTE provide the option to select treatment in metastatic hormone-sensitive prostate cancer with and without Taxotere to meet patients’ individual needs and preferences.”

References:

• “FDA Grants Accelerated Approval to Datopotamab Deruxtecan-dlnk for EGFR-Mutated Non-Small Cell Lung Cancer. News release. U.S. Food and Drug Administration. June 23, 2025. Accessed July 1,, 2025.
• “Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT.” News release. Telix. June 23, 2025. Accessed June 26, 2025. July 1, 2025.
• “FDA Approves Tafasitamab-cxix for Relapsed or Refractory Follicular Lymphoma.” News release. U.S. Food and Drug Administration. June 18, 2025. Accessed July 1, 2025.
• “U.S. FDA Approves Tablet Formulation of BeOne’s BRUKINSA® for All Approved Indications.” News Release. BeOne Medicines Ltd. June 11, 2025. Accessed July 1, 2025.
• “FDA Approves Neooadjuvant and Adjuvant Pembrolizumab for Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma.” News release. The Food and Drug Administration. June 12, 2025. Accessed July 1, 2025.
• “FDA Approves Taletrectinib for ROS1-positive Non-Small Cell Lung Cancer.” News release. The Food and Drug Administration. June 11, 2025. Accessed July 1, 2025.
• “FDA Approves Darolutamide for Metastatic Castration-Sensitive Prostate Cancer.” News release. The Food and Drug Administration. June 3, 2025. Accessed July 1, 2025.

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