Oncology FDA Approval– category –
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Oncology Drug Approval News Flash: Niraparib plus abiraterone acetate and prednisone approved for BRCA2-mutated metastatic castration-sensitive prostate cancer
FDA approval summary On December 12, 2025, the U.S. Food and Drug Administration (FDA) approved niraparib and abiraterone acetate (Akeega, Janssen Biotech, Inc.) with prednisone for adult patients with deleterious or suspected deleteriou... -
Oncology Drug Approval News Flash：FDA approves lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma
On December 4, 2025, the U.S. Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., a Bristol Myers Squibb company), a CD19-directed CAR T-cell therapy, for adult patients with relapsed or ref... -
Oncology Drug Approval News Flash：FDA grants traditional approval to pirtobrutinib (Jaypirca) for adults with relapsed or refractory CLL/SLL after covalent BTK inhibitor therapy
On December 3, 2025, the U.S. Food and Drug Administration granted traditional approval to pirtobrutinib (Jaypirca, Eli Lilly and Company) for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic l... -
Oncology Drug Approval News Flash：FDA approves durvalumab (Imfinzi) plus FLOT as perioperative therapy for resectable gastric and GEJ adenocarcinoma
On November 25, 2025, the U.S. Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by sin... -
Oncology Drug Approval News Flash: FDA approves perioperative pembrolizumab plus enfortumab vedotin-ejfvfor cisplatin-ineligible muscle invasive bladder cancer (MIBC)
On November 21, 2025, the U.S. FDA approved pembrolizumab (Keytruda / Keytruda Qlex) in combination with enfortumab vedotin-ejfv (Padcev) as neoadjuvant and adjuvant therapy for adults with muscle invasive bladder cancer (MIBC) who are e... -
Oncology Drug Approval News Flash: FDA Grants Full Approval to Tarlatamab-dlle for ES-SCLC and Accelerated Approval to Sevabertinib for HER2-Mutated NSCLC
On November 19, 2025, the U.S. Food and Drug Administration (FDA) granted traditional approval to tarlatamab-dlle (Imdelltra, Amgen) for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease progressed after platinum... -
Oncology Drug Approval News Flash: FDA Approves Selumetinib (KOSELUGO) for Adults with Neurofibromatosis Type 1 and Symptomatic, Inoperable Plexiform Neurofibromas
On November 19, 2025, the U.S. Food and Drug Administration (FDA) approved selumetinib (KOSELUGO, AstraZeneca) for adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN). Previously appro... -
Oncology Drug Approval News Flash: FDA Approves Epcoritamab-bysp (Epkinly) with R² for Relapsed or Refractory Follicular Lymphoma
On November 18, 2025, the U.S. Food and Drug Administration (FDA) approved epcoritamab-bysp (Epkinly, Genmab / AbbVie) in combination with lenalidomide and rituximab (R²) for adults with relapsed or refractory follicular lymphoma (FL). T... -
Oncology Drug Approval News Flash: FDA Approves Poherdy (pertuzumab-dpzb) as the First Interchangeable Biosimilar to Perjeta
On November 13, 2025, the U.S. Food and Drug Administration (FDA) approved Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics) as the first interchangeable biosimilar to Perjeta (pertuzumab, Genentech). This marks a historic step in ex... -
Oncology Drug Approval News Flash: FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma
On November 6, 2025, the U.S. Food and Drug Administration (FDA) approved Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech, Inc.) for the treatment of adults with high-risk smoldering multiple myeloma (SMM). This mark... -
Oncology Drug Approval News Flash: FDA Re-Approves Blenrep (Belantamab Mafodotin) in Combination Therapy for Multiple Myeloma
In October 2025, the U.S. Food and Drug Administration (FDA) granted re-approval to belantamab mafodotin (Blenrep), GSK’s anti-BCMA antibody–drug conjugate (ADC), for use in combination with bortezomib and dexamethasone in patients with ... -
Oncology Drug Approval News Flash: FDA Approves Lurbinectedin Plus Atezolizumab for Maintenance in Extensive-Stage Small Cell Lung Cancer
On October 2, 2025, the U.S. Food and Drug Administration (FDA) approved lurbinectedin (Zepzelca, Jazz Pharmaceuticals) in combination with atezolizumab (Tecentriq, Genentech) or atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) fo... -
Oncology Drug Approval News Flash: FDA Approves Imlunestrant (Inluriyo) for ER-Positive, HER2-Negative, ESR1-Mutated Breast Cancer
On September 25, 2025, the U.S. Food and Drug Administration (FDA) approved Eli Lilly’s estrogen receptor antagonist Imlunestrant (Inluriyo) for the treatment of adult patients with ER-positive, HER2-negative, ESR1-mutated advanced or me... -
News Watch: in vivo CAR-T RACE (2025 Global Update)
Last updated: 2025-09-01 JST What you will learn Three-Line SummaryWhy in vivo (now)?Company Highlights (Q3 2025)Two Paths, One GoalClinical KPIs to Watch Lead: The shift from ex vivo to in vivo CAR-T is turning into a full-blown race. B... -
Viking’s VK2735 Plunge: What 50% Stock Drop Reveals About the Novo–Lilly Duopoly Era
On August 19, 2025, U.S.-based biotech company Viking Therapeutics announced results from its Phase 2 trial of the oral obesity drug VK2735. While the therapy demonstrated up to 12.2% weight loss over 13 weeks, a high discontinuation rat... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for HER2 TKD-Mutated NSCLC
On August 8, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.), a kinase inhibitor, for adults with unresectable or metastatic non-squamo... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Dordaviprone (Modeyso) for H3 K27M-Mutant Diffuse Midline Glioma
On August 6, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dordaviprone (Modeyso, Jazz Pharmaceuticals), a protease activator, for adult and pediatric patients (≥1 year) with progressive H3 K27M-mutant... -
CD388 (Cidara): What “One-Shot Seasonal Flu Protection” Could Mean for Vaccine Strategy
A New Era in Flu Prevention? — CD388 Shows One-Shot Seasonal Protection Introduction Flu prevention has long relied on seasonal vaccines, but a new innovation may challenge that paradigm. CD388, a long-acting antiviral developed by Cidar... -
Oncology Drug Approval News Flash: Sunvozertinib (Zegfrovy) Approved for EGFR Exon20 Insertion-Positive NSCLC
[FDA Accelerated Approval] New Oral TKI for Advanced NSCLC with EGFR Exon20 Insertions On July 2, 2025, the FDA granted accelerated approval to Sunvozertinib (brand name: Zegfrovy) for the treatment of adult patients with locally advance... -
Oncology Drug Approval News Flash: FDA Grants Accelerated Approval to Lynozyfic (linvoseltamab) for Relapsed/Refractory Multiple Myeloma
[FDA Approval] BCMA/CD3 Bispecific Antibody Approved on July 2, 2025 On July 2, 2025, the U.S. Food and Drug Administration (FDA) granted accelerated approval to linvoseltamab (brand name: Lynozyfic) for the treatment of adults with rela...
