Breaking Down Every FDA Approval Across Oncology During July 2025

In July of 2025, the U.S. Food and Drug Administration approved various anti-cancer treatments and therapeutic approaches across a range of disease types, such as multiple myeloma, non-small cell lung cancer (NSCLC), liver cancer, and more.

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

FDA Grants Accelerated Approval to Lynozyfic for Multiple Myeloma

The FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt) for patients with relapsed or refractory multiple myeloma who have received at least four prior treatments, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Lynozyfic is a bispecific B-cell maturation antigen-directed CD3 T-cell engager.

The approval is based on results from the LINKER-MM1 trial, where the overall response rate was 70%. Of those who responded, 89% maintained a response at 9 months and 72% at 12 months, with a median follow-up of 11.3 months.

However, serious side effects were observed during the trial. Cytokine release syndrome occurred in 46% of patients, though fewer than 1% experienced severe (grade 3; severe) cases. Neurologic toxicity, including immune effector cell-associated neurotoxicity, was reported in 54% of patients, with 8% experiencing grade 3 or 4 (life-threatening) events. Due to these risks, Lynozyfic carries a black box warning in its prescribing information.

FDA Approved Zegfrovy in EGFR Exon 20 NSCLC

The FDA has granted accelerated approval to Zegfrovy (sunvozertinib) for patients with locally advanced or metastatic NSCLC that harbors epidermal growth factor receptor (EGFR) exon 20 insertion mutations, and whose disease has progressed following platinum-based chemotherapy. Alongside this approval, the FDA also authorized the use of the Oncomine Dx Express Test to detect EGFR exon 20 insertion mutations in patients who may be eligible for treatment with Zegfrovy.

The approval was based on efficacy data evaluated by a blinded independent review committee (BIRC) using RECIST v1.1 criteria. The primary measure was overall response rate (ORR), which reflects the percentage of patients whose tumors shrink or disappear after treatment. The ORR was 46%. An additional measure, duration of response (DOR), indicated how long the treatment continued to control the cancer after a response occurred; the DOR was 11.1 months.

SIR-Spheres FDA-Approved for Liver Cancer Treatment

SIR-Spheres® Y-90 resin microspheres has been FDA-approved the treatment of unresectable hepatocellular carcinoma (HCC), making it the only radioembolization therapy in the U.S. approved for both metastatic colorectal cancer (mCRC) in the liver and HCC. This approval was announced in a news release from Sirtex Medical.

“The expanded indication makes SIR-Spheres the only Y-90 treatment approved in the U.S. for both HCC and mCRC,” Matt Schmidt, CEO of Sirtex, stated in the news release. “This milestone reflects our ongoing commitment to delivering flexible, personalized therapies — with multiple dose options available daily — that empowers physicians to treat patients when and where it works best.”

Stoboclo and Osenvelt Approved as Biosimilars For Some Cancers

Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), biosimilars to Prolia and Xgeva, are now available in the U.S. for use in conditions such as breast cancer, prostate cancer, multiple myeloma, and bone metastases from solid tumors, according to a news release from Celltrion.

Biosimilars are lower-cost alternatives to specific biologic drugs, including those used in cancer treatment, as noted by the American Cancer Society. Although they are not identical to the original medications, they are highly similar and must meet rigorous FDA standards to ensure safety and effectiveness.

"We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars. We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option,” Thomas Nusbickel, chief commercial officer at Celltrion USA, said of the approval. " Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems."

Doptelet FDA Approved for Pediatric Immune Thrombocytopenia

The FDA approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in pediatric patients aged one year and older who have persistent or chronic immune thrombocytopenia and have not responded adequately to a previous treatment, according to a news release from Sobi.

This approval also includes a new child-friendly formulation, Doptelet Sprinkle (avatrombopag) oral granules, specifically intended for use in children between the ages of one and under six years.

“Doptelet represents a significant advancement in the treatment of children and adolescents with persistent or chronic immune thrombocytopenia. This therapy offers simple, flexible administration because it is oral, available as a tablet and now as a new pediatric sprinkle formulation and has no food restrictions. The approval of Doptelet for pediatric immune thrombocytopenia offers families a new treatment option that can help address challenges in managing immune thrombocytopenia in pediatric patients," Dr. Rachael Grace said of the advancement.

Grace is a pediatric hematologist and director, Hematology Clinical Research at Dana-Farber/Boston Children's Cancer and Blood Disorders Center, and lead investigator of the AVA-PED-301 study, which is a trial that supported the approval.

References

1. “FDA Grants Accelerated Approval To Linvoseltamab-gcpt For Relapsed Or Refractory Multiple Myeloma” by U.S. Food And Drug Administration. July 2, 2025.
2. “FDA Grants Accelerated Approval To Sunvozertinib For Metastatic Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations,” by U.S. Food and Drug Administration. July 2, 2025.
3. “Thermo Fisher’s NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling,” by Thermo Fisher Scientific. News release. July 3, 2025.
4. “Sirtex Medical’s SIR-Spheres® Y-90 Resin Microspheres Receive FDA Approval for the Treatment of Unresectable Hepatocellular Carcinoma,” by Sirtex Medical. News release. July 7, 2025.
5. “Celltrion USA announces U.S. launch of denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo),” by Celltrion. News release. July 7, 2025.
6. "Biosimilar Medicines," by American Cancer Society. https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs.html
7. “Sobi Announces U.S. Food and Drug Administration Approves Doptelet® (avatrombopag) for the Treatment of Thrombocytopenia in Pediatric Patients One Year and Older with Persistent or Chronic Immune Thrombocytopenia (ITP),” by Sobi. News release. July 25, 2025.

For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.