FDA Approves Six New Cancer Therapies in December 2025

The U.S. Food and Drug Administration (FDA) approved six new therapies in December 2025 for blood cancers, prostate cancer, lung cancer and supportive care. Approvals include both traditional and accelerated pathways and reflect results from recent clinical trials.

FDA Grants Traditional Approval to Jaypirca in CLL, SLL

The FDA granted traditional approval to Jaypirca (pirobrutinib) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who were previously treated with a covalent Bruton tyrosine kinase inhibitor.

The decision converts the drug’s prior accelerated approval and is supported by data from the randomized, open-label BRUIN-CLL-321 trial, which enrolled 238 patients with CLL or SLL previously treated with a covalent BTK inhibitor. Patients were randomized to receive Jaypirca or investigator’s choice of Zydelig (idelalisib) plus Rituxan (rituximab) or bendamustine plus Rituxan, with crossover to Jaypirca allowed after confirmed disease progression.

Median progression-free survival was 11.2 months with Jaypirca versus 8.7 months with investigator’s choice therapy. Fifty of 119 patients in the investigator’s choice arm crossed over to Jaypirca.

According to the FDA, prescribing information for Jaypirca includes warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, secondary primary malignancies, hepatotoxicity and embryo-fetal toxicity.

FDA Approves Breyanzi for Relapsed or Refractory Marginal Zone Lymphoma

The FDA approved Breyanzi (lisocabtagene maraleucel) for adults with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy.

Approval was based on results from the open-label, single-arm TRANSCEND FL-MZL Cohort trial, which included patients who had received at least two prior therapies or relapsed after hematopoietic stem cell transplant. Patients received a single dose of Breyanzi following lymphodepleting chemotherapy.

Among 77 leukapheresed patients, the overall response rate was 84.4%, with a complete response rate of 55.8%. Median duration of response was not reached at the time of analysis.

The FDA noted that prescribing information for Breyanzi includes warnings and precautions for cytokine release syndrome, neurologic toxicities, hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies and immune effector cell–associated hemophagocytic lymphohistiocytosis-like syndrome.

FDA Approves Rybrevant Faspro for EGFR-Mutated NSCLC

The FDA approved Rybrevant Faspro (amivantamab and hyaluronidase-lpuj), a subcutaneous formulation, for patients with epidermal growth factor receptor-mutated non-small cell lung cancer across all indications.

The approval was supported by data from the phase 3 PALOMA-3 trial, which enrolled 418 patients with EGFR-mutated advanced or metastatic NSCLC who had received prior therapy. The study compared Lazcluze (lazertinib) with either subcutaneous Rybrevant Faspro or intravenous Rybrevant, with co-primary end points focused on pharmacokinetics.

Rybrevant Faspro met both co-primary pharmacokinetic end points. Additional analyses showed longer duration of response, improved progression-free survival and longer overall survival compared with intravenous administration. At 12 months, 65% of patients receiving the subcutaneous formulation were alive compared with 51% of those receiving the intravenous formulation.

FDA Grants Regular Approval to Rubraca in mCRPC

The FDA granted regular approval to Rubraca (rucaparib) for adults with deleterious BRCA-mutated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.

The approval is supported by results from the randomized, open-label TRITON3 trial, which enrolled 405 patients with mCRPC who had progressed on a prior androgen receptor pathway inhibitor. Patients were randomized to Rubraca or physician’s choice of therapy, with radiographic progression-free survival as the primary end point.

Among patients with BRCA mutations, median radiographic progression-free survival was 11.2 months with Rubraca versus 6.4 months with physician’s choice therapy. Median overall survival was 23.2 months and 21.2 months, respectively.

According to the FDA, prescribing information for Rubraca includes warnings and precautions for myelodysplastic syndrome or acute myeloid leukemia and embryo-fetal toxicity.

FDA Grants Accelerated Approval to Lunsumio VELO in Follicular Lymphoma

The FDA granted accelerated approval to Lunsumio VELO (mosunetuzumab), a subcutaneous CD20xCD3 bispecific antibody, for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

The decision was based on results from the phase 1/2 GO29781 study. In the trial, 75% of patients achieved an objective response, including a complete response rate of 59%. Among responders, the median duration of response was 22.4 months.

The most common side effects reported in at least 20% of patients included injection-site reactions, fatigue, skin rash, cytokine release syndrome, COVID-19 infection, muscle or joint pain and diarrhea. Cytokine release syndrome occurred in 30% of patients, with most cases mild to moderate and typically resolving within a median of two days.

FDA Approves Armlupeg as Biosimilar to Neulasta

The FDA approved Armlupeg (pegfilgrastim-unne) as a biosimilar to Neulasta for patients with non-myeloid malignancies receiving myelosuppressive anticancer therapy associated with febrile neutropenia, as well as for increasing survival after acute exposure to myelosuppressive radiation.

“We are proud to achieve the FDA approval for our first biosimilar, Armlupeg,” Vinita Gupta, CEO of Lupin, said in a news release. “This step marks a pivotal step in Lupin’s ongoing commitment to providing more affordable, accessible medicines to U.S. patients.”

References

1. “Lupin Receives Approval from U.S. FDA for Biosimilar Armlupeg (pegfilgrastim-unne)” press release, Lupin Limited, December 1 2025.
2. “FDA approves Roche’s Lunsumio VELO™ for subcutaneous use in relapsed or refractory follicular lymphoma.” News Release. Roche.
3. FDA grants regular approval to rucaparib for metastatic castration-resistant prostate cancer, by the U.S. FDA. News release; Dec. 17, 2025.
4. “U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Enables the Simplest, Shortest Administration Time for a First-Line Combination Regimen when combined with LAZCLUZE® (lazertinib),” by Johnson & Johnson. News release; Dec. 17, 2025.
5. “FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
6. “FDA grants traditional approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma,” FDA; https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-pirtobrutinib-chronic-lymphocytic-leukemia-and-small-lymphocytic?utm_medium=email&utm_source=govdelivery

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