July FDA Oncology Approvals Include Options for NSCLC, Myeloma, and More

The FDA issued approvals in hematologic, lung, and liver cancers.

Oncology drug approvals in July 2025 brought expanded treatment options across several tumor types, including relapsed or refractory multiple myeloma, EGFR exon 20–mutated non–small cell lung cancer (NSCLC), and unresectable hepatocellular carcinoma (HCC).

The FDA also approved a generic formulation of ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor for patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and Waldenström macroglobulinemia.

Linvoseltamab Gets Accelerated Approval in Relapsed/Refractory Myeloma

On July 2, the FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic) for the treatment of adult patients with relapsed/refractory multiple myeloma following at least 4 previous lines of therapy, including a proteasome inhibitor (PI), a CD38-targeting monoclonal antibody, and an immunomodulatory agent (IMiD).¹

The CD3 bispecific T-cell engager (BiTE) was evaluated in the open-label, multicenter, multi-cohort LINKER-MM1 trial (NCT03761108); these trial results are what supported linvoseltamab’s current approval. Linvoseltamab targets the B-cell maturation antigen (BCMA).

The objective response rate (ORR) of patients receiving linvoseltamab was 70% (95% CI, 59%-80%), as assessed by blinded independent review committee per International Myeloma Working Group criteria. Additionally, 45% achieved a complete response (CR) or better, and patients had a 0.95-month median time to first response (range, 0.5-6), according to a news release from Regeneron, the drug’s developer.²

The estimated duration of response (DOR) was 89% (95% CI, 77%%-95%) at 9 months and 72% (95% CI, 54%-84%) at 12 months. The median DOR was not reached (95% CI, 12-NE). The median follow-up for responders was 11.3 months, according to the FDA.¹

Linvoseltamab’s prescribing information contains a warning for potentially fatal cytokine release syndrome (CRS) as well as immune effector cell-associated neurotoxicity (ICANS), according to the FDA’s announcement. Further, 46% of patients receiving the recommended dose of linvoseltamab experienced CRS, and 54% of patients reported neurologic toxicities including ICANS. For less than 1% of patients, CRS was grade 3, and for 8% of patients, neurologic toxicities were grade 3/4.

Sunvozertinib Nabs Accelerated Approval in EGFR Exon 20+ NSCLC

Also on July 2, the FDA issued accelerated approval to sunvozertinib (Zegfrovy) for use in adult patients with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations following progression on platinum-based chemotherapy.³

Along with this approval, the FDA announced its approval of a companion diagnostic test called Oncomine Dx Express Test to help identify EGFR exon 20 insertion mutations.

The approval of sunvozertinib is based on data from the international, open-label, dose randomization phase 2 WU-KONG1B trial (NCT03974022). Results showed that the ORR in patients taking sunvozertinib was 46% (95% CI, 35%-57%) and the DOR was 11.1 months (95% CI, 8.2-not evaluable [NE]).

As noted in the FDA’s announcement, sunvozertinib’s prescribing information contains warnings for interstitial lung disease (ILD), pneumonitis, gastrointestinal adverse reactions, dermatologic adverse reactions, ocular toxicity, and embryo-fetal toxicity.

SIR-Spheres Y-90 Resin Microspheres Approved for Unresectable HCC

On July 7, the FDA approved SIR-Spheres® Y-90 resin microspheres for the treatment of patients with unresectable HCC, per a news release from Sirtex Medical, the developer of the product.⁴

SIR-Spheres are biocompatible resin microspheres that are between 20 and 60 microns in diameter.² They contain yttrium-90 (Y-90), a high-energy pure beta-emitting isotope that yields no primary gamma emission.

Approval of SIR-Spheres is supported by data from the prospective, multicenter, open-label, single-arm DOORwaY90 study (NCT04736121), which evaluated the efficacy of SIR-Spheres in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1 and B2 HCC, with single lesion size of at most 8 cm.⁵The best ORR over 9 months (the trial’s primary end point) was 98.5%, and the median DOR was greater than 300 days.⁴ All evaluable patients demonstrated response to treatment, yielding a 100% disease control rate.

According to safety information for SIR-Spheres listed on Sirtex Medical’s website, the most common adverse events (AEs) associated with the treatment are fever, mild to moderate liver function test abnormalities, abdominal pain, nausea and vomiting, and diarrhea.⁶ The website also mentions that certain premedications are recommended.

Generic Ibrutinib Tablet Gets Tenative Green Light in CLL/SLL, Waldenström Macroglobulinemia

The FDA granted tentative approval to Zydus Lifesciences Limited’s abbreviated new drug application (ANDA) seeking the approval of the company’s generic ibrutinib tablet for use in some approved indications.⁷

The tablet’s indications include CLL and SLL with 17p deletion and Waldenström macroglobulinemia.⁸ The tentative approval will allow tablets of 140 mg, 280 mg, 420 mg, and 560 mg to be used to treat these patient populations. The approval is currently tentative due to market exclusivity limitations pertaining to Pharmacyclics’ ibrutinib (Imbruvica) tablets.⁷

The most common AEs associated with ibrutinib for patients with B-cell malignancies, occurring in at least 30% of patients as noted in ibrutinib’s label, are thrombocytopenia, diarrhea, fatigue, musculoskeletal pain, neutropenia, rash, anemia, bruising, and nausea.

References

1. FDA grants accelerated approval to linvoseltamab-gcpt for relapsed or refractory multiple myeloma. FDA. July 2, 2025. Accessed July 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-linvoseltamab-gcpt-relapsed-or-refractory-multiple-myeloma
2. Lynozyfic™ (linvoseltamab-gcpt) receives FDA accelerated approval for treatment of relapsed or refractory multiple myeloma. Regeneron. July 2, 2025. Accessed July 2, 2025. https://www.globenewswire.com/news-release/2025/07/02/3109328/0/en/Lynozyfic-linvoseltamab-gcpt-Receives-FDA-Accelerated-Approval-for-Treatment-of-Relapsed-or-Refractory-Multiple-Myeloma.html
3. FDA grants accelerated approval to sunvozertinib for metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. FDA. July 2, 2025. Accessed July 2, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sunvozertinib-metastatic-non-small-cell-lung-cancer-egfr-exon-20
4. Sirtex Medical's SIR-Spheres® Y-90 resin microspheres receive fda approval for the treatment of unresectable hepatocellular carcinoma. Sirtex Medical Inc. News release. July 7, 2025. Accessed July 7, 2025. https://www.prnewswire.com/news-releases/sirtex-medicals-sir-spheres-y-90-resin-microspheres-receive-fda-approval-for-the-treatment-of-unresectable-hepatocellular-carcinoma-302498439.html
5. Selective Internal Radiation Therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres on dor & orr in unresectable hepatocellular carcinoma patients (DOORwaY90). ClinicalTrials.Gov. February 3, 2021. Updated February 5, 2025. Accessed July 7, 2025. https://clinicaltrials.gov/study/NCT04736121
6. SIR-Spheres® Y-90 resin microspheres, risk and potential adverse events. Sirtex Medical Inc. Accessed July 7, 2025. https://www.sirtex.com/sir-spheres/risks_adverse-events
7. ANDA 214296 Tentative Approval. FDA. Letter of tentative approval. July 22, 2025. Accessed July 25, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/214296Orig1s000TAltr.pdf
8. Zydus receives tentative approval from USFDA for ibrutinib tablets 140 mg, 280 mg, and 420 mg. News release. Zydus Lifesciences Limited. July 24, 2025. Accessed July 25, 2025. https://zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-tentative-approval-from-USFDA-for-Ibrutinib-tablets-140-mg--280-mg--and-420-mg.pdf