Tools: Vol. 41, No. 1

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Approved Drugs

On November 6, 2025, the FDA approved Darzalex Faspro® (daratumumab and hyaluronidase-fihj) (Janssen Biotech) for adults with high-risk smoldering multiple myeloma.
On November 13, the FDA approved Komzifti™ (ziftomenib) (Kura Oncology), a menin inhibitor, for adults with relapsed or refractory acute myeloid leukemia with a susceptible nucleophosmin 1 mutation who have no satisfactory alternative treatment options.
On November 13, the FDA approved Poherdy® (pertuzumab-dpzb) (Shanghai Henlius Biologics) as an interchangeable biosimilar to Perjeta® (pertuzumab) (Genentech).
On November 18, the FDA approved Epkinly® (epcoritamab-bysp) (Genmab) with lenalidomide and rituximab for relapsed or refractory follicular lymphoma (FL). The FDA also granted traditional approval to Epkinly as monotherapy for relapsed or refractory FL after 2 or more lines of systemic therapy.
On November 19, the FDA approved Koselugo (selumetinib) (AstraZeneca) for adults with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas.
On November 19, the FDA granted traditional approval to Darzalex Faspro (daratumumab and hyaluronidase-fihj) (Janssen Biotech) with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain amyloidosis.
On November 19, the FDA granted accelerated approval to Hyrnuo® (sevabertinib) (Bayer), a kinase inhibitor, for adults with locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLS) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.
On November 19, the FDA granted traditional approval to Imdelltra (tarlatamab-dlle) (Amgen) for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
On November 21, the FDA approved Keytruda® (pembrolizumab) (Merck) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) (Merck) with Padcev® (enfortumab vedotin-ejfv) (Astellas Pharma) as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer who are ineligible for cisplatin.
On November 25, the FDA approved Imfinzi (durvalumab) (AstraZeneca) with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.
On December 3, the FDA granted traditional approval to Jaypirca (pirtobrutinib) (Lilly) for adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have previously been treated with a covalent BTK inhibitor.
On December 4, the FDA approved Breyanzi® (lisocabtagene maraleucel) (Juno Therapeutics) for adults with relapsed or refractory marginal zone lymphoma who have received at least 2 prior lines of systemic therapy.
On December 12, the FDA approved Akeega® (niraparib and abiraterone acetate) (Janssen Biotech) with prednisone for adults with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer, as determined by an FDA-approved test.
On December 15, the FDA approved Enhertu® (fam-trastuzumab deruxtecan-nxki) (Daiichi Sankyo) in combination with pertuzumab for the first-line treatment of adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test.
On December 17, the FDA approved Rubraca (rucaparib) (pharmaand) for adults with a deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer previously treated with an androgen receptor-directed therapy.
On December 17, the FDA approved Rybrevant Faspro™ (amivantamab and hyaluronidase-lpuj) (Janssen Biotech) for subcutaneous injection for adult patients across all indications approved for the intravenous formulation of Rybrevant® (amivantamab) (Janssen Biotech)

Drugs in the News

The FDA designated Stoboclo® (denosumab-bmwo) (Celltrion) and Osenvelt® (denosumab-bmwo) (Celltrion) as interchangeable biosimilars to the reference products Prolia® (denosumab) and Xgeva® (denosumab), respectively, for all approved indications.
The FDA granted orphan drug designation to M2T-CD33 (LTI-214) (Leukogene Therapeutics) for the treatment of acute myeloid leukemia.
The FDA granted fast track designation to AVZO-1418 (DB-1418) (Avenzo Therapeutics), an EGFR/HER3 bispecific antibody-drug conjugate, for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR tyrosine kinase inhibitor.
The FDA granted orphan drug designation tinostamustine (Purdue Pharma) for the treatment of malignant gliomas.
The FDA granted fast track designation to alnodesertib (Artios Pharma Limited), a targeted therapy that blocks cancer cells’ ability to repair DNA damage, in combination with a low dose of irinotecan, a chemotherapy drug that causes that damage, for the treatment of metastatic colorectal cancer.
The FDA granted regenerative medicine advanced therapy designation to MB-105 (March Biosciences), an autologous CD5-targeted CAR-T cell therapy, in development for relapsed/refractory CD5-positive T-cell lymphoma.
The FDA granted fast track designation to 4A10 (Allterum Therapeutics), a monoclonal antibody targeting the interleukin-7 receptor alpha for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia.
The FDA granted fast track product designation to FOG-001 (Parabilis Medicines), an investigational Helicon peptide, for the treatment of desmoid tumors.
The FDA granted fast track designation to ITM-94 (ITM Isotope Technologies) as a diagnostic agent for the detection of clear cell renal cell carcinoma.
The FDA granted fast track designation to DPTX3186 (Dewpoint Therapeutics), an oral condensate modulator targeting the Wnt/β-catenin pathway, for the treatment of gastric cancer.
The FDA granted orphan drug designation to OBI-902 (OBI Pharma), an antibody-drug conjugate, for the treatment of cholangiocarcinoma.
The FDA granted fast track designation to AVZO-103 (Avenzo Therapeutics), a Nectin4/TROP2 bispecific antibody-drug conjugate.
The FDA granted orphan drug designation to NBM-BMX (NovelWise), a selective HDAC8 inhibitor, for the treatment of uveal melanoma.
The FDA granted priority review to a new drug application for sonrotoclax (BeOne Medicines), a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, following treatment with a Bruton’s tyrosine kinase inhibitor.
The FDA granted fast track designation to zotiraciclib (ZTR/TG02) (Cothera Bioscience) for the treatment of patients with recurrent high-grade gliomas harboring IDH1 or IDH2 mutations.
The FDA granted fast track designation to CLN-049 (Cullinan Therapeutics), a novel FLT3xCD3 T cell engager, for the treatment of relapsed/refractory acute myeloid leukemia.
The FDA granted fast track designation to CT-P70 (Celltrion), an antibody-drug conjugate-based anticancer drug candidate.
The FDA granted breakthrough therapy designation to INCA033989 (Incyte), a mutant calreticulin (mutCALR)-targeted monoclonal antibody, for the treatment of patients with essential thrombocythemia harboring a Type 1 CALR mutation who are resistant or intolerant to at least 1 cytoreductive therapy.
The FDA granted orphan drug designation to CHM CDH17 (Chimeric Therapeutics) for the treatment of gastric cancer.
The FDA granted regenerative medicine advanced therapy designation to SENTI-202 (Senti Biosciences), a chimeric antigen receptor natural killer investigational cell therapy that is currently in development for the treatment of relapsed/refractory hematologic malignancies.
The FDA granted orphan drug designation to risvutatug rezetecan (GSK), a B7-H3-targeted antibody-drug conjugate, for the treatment of small-cell lung cancer.
The FDA granted orphan drug designation to AJ1-11095 (Ajax Therapeutics) for the treatment of myelofibrosis.
The FDA accepted and granted priority review to the supplemental biologics license application for Opdivo® (nivolumab) (Bristol Myers Squibb) in combination with doxorubicin, vinblastine and dacarbazine for adult and pediatric (12 years and older) patients with previously untreated stage III or IV classical Hodgkin Lymphoma.
The FDA granted orphan drug designation to roxadustat (FibroGen) for the treatment of myelodysplastic syndromes.
The FDA designated muzastotug (Adagene), in combination with anti-PD-1 therapy, Keytruda® (pembrolizumab) (Merck), as a fast track product for adult patients with microsatellite stable metastatic colorectal cancer without current or active liver metastases.
The FDA granted fast track designation to BGB-B2033 (BeOne Medicines), a GPC3x4-1BB bispecific antibody, for the treatment of adult patients with hepatocellular carcinoma with disease progression on or after prior systemic treatment.
The FDA granted fast track designation to CBI-1214 (Cartography Biosciences), a T-cell engager being developed for the treatment of colorectal cancer.
The FDA granted breakthrough therapy designation to JSKN003 (Alphamab Oncology), a biparatopic HER2-targeting antibody-drug conjugate, for the treatment of adult patients with advanced or metastatic platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal, or fallopian tube cancers expressing HER2 who have received prior treatment with bevacizumab.
The FDA granted breakthrough therapy designation to Enhertu (trastuzumab deruxtecan) (AstraZeneca and Daiichi Sankyo) for the treatment of adult patients with HER2-positive early breast cancer with residual invasive disease in the breast and/or axillary lymph nodes after neoadjuvant treatment and high risk of disease recurrence.
The FDA granted orphan drug designation to Envafolimab (KN035) (Alphamab Oncology) for the treatment of gastric cancer and gastroesophageal junction cancer.
The FDA granted orphan drug designation to SNB-101 (SN Bioscience), a polymer nanoparticle drug, for the treatment of gastric cancer.

Devices and Assays

The FDA approved an investigational device exemption application for Alpha Tau to initiate a pilot study for the treatment of patients with locally recurrent prostate cancer using the company’s Alpha DaRT technology.
The FDA approved Dilon Technologies’ MarginProbe® 2 system, a next-generation device for real-time intraoperative margin assessment in breast cancer surgery

Articles in this issue