The Fda Anticipates Approving Five New Drugs By October 2025
The Prescription Drug User Fee Act (PDUFA) date marks the deadline by which the U.S. Food and Drug Administration (FDA) must complete its review of a New Drug Application (NDA) or Biologics License Application (BLA).
The standard review cycle is typically 10 months, while drugs granted priority review receive a shorter 6-month review period.
Below are several key PDUFA dates in October 2025 (Five New Drugs By October 2025) for novel therapies across oncology, immunology, ophthalmology, and haematology, news from HKdengyuemed.
1️⃣ Lurbinectedin + Atezolizumab for Extensive-Stage Small Cell Lung Cancer (ES-SCLC)
PDUFA Date: 7 October 2025
The FDA has granted Five New Drugs By October 2025, priority Review to the supplemental NDA (sNDA) for Lurbinectedin in combination with Atezolizumab as a first-line maintenance therapy for ES-SCLC patients who have not progressed following induction therapy with Atezolizumab + Carboplatin + Etoposide.
- Mechanism: Lurbinectedin, an RNA polymerase II inhibitor, works synergistically with Atezolizumab, a PD-L1 monoclonal antibody, to enhance antitumour activity.
- Trial Basis: Phase 3 IMforte trial (NCT05091567) involving 660 patients.
- Results:
- 46% reduction in risk of progression or death (HR 0.54; P<0.0001)
- Median PFS: 5.4 vs. 2.1 months
- 27% reduction in risk of death (HR 0.73; P=0.0174)
If approved, this combination could establish a new standard of care for ES-SCLC maintenance therapy.
2️⃣ Tezepelumab for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
PDUFA Date: 19 October 2025
Tezepelumab (Tezspire), a TSLP antagonist currently approved for severe asthma, is under FDA review for adult patients with CRSwNP.
- Study: Phase 3 WAYPOINT trial (NCT04851964)
- Results:
- Reduced nasal polyp size (Δ = -2.065; P<0.0001)
- Improved nasal congestion (Δ = -1.028; P<0.0001)
- 98% reduction in need for follow-up surgery; 88% reduction in systemic corticosteroid use
If approved, Tezepelumab would expand its indications beyond asthma into upper airway inflammatory diseases.
3️⃣ SYD-101 for Paediatric Myopia
PDUFA Date: 23 October 2025
SYD-101, a low-dose atropine sulfate ophthalmic solution, is being evaluated for slowing myopia progression in children aged 3–14 years.
- Trial: Phase 3 STAR trial (NCT03918915) with 852 participants
- Key Endpoint: Reduced proportion of patients with >0.75D progression
- Significance: If approved, SYD-101 would become the first FDA-approved drug for myopia control in children.
4️⃣ Revumenib for NPM1-Mutated Acute Myeloid Leukaemia (AML)
PDUFA Date: 25 October 2025
Revumenib (REVUFORJ), a first-in-class Menin inhibitor, is under FDA review for relapsed/refractory AML with NPM1 mutation.
- Current Approval: For AML with KMT2A rearrangements (since Nov 2024)
- Study: Phase 1/2 AUGMENT-101 (NCT04065399)
- Results:
- CR/CRh rate: 26% (95% CI, 16.6–37.2)
- ORR: 48.1%
- Median CR/CRh duration: 4.7 months
If approved, Revumenib will be the first Menin inhibitor authorised for NPM1-mutated AML, expanding precision oncology in haematologic malignancies.
5️⃣ Obinutuzumab for Lupus Nephritis
PDUFA Date: October 2025
Obinutuzumab (Gazyva), a CD20-directed cytolytic antibody, is under FDA review for lupus nephritis.
- Study: Phase 3 REGENCY trial (NCT04221477) with 271 patients
- Primary Endpoint: Complete Renal Response (CRR) at Week 76
- Results:
- Significantly higher CRR rates with Obinutuzumab + standard therapy
- Clinically meaningful improvements in steroid tapering and renal outcomes
If approved, Obinutuzumab could offer a new biologic option for patients with severe lupus nephritis.
🔍 Summary
Five New Drugs By October 2025, marks a critical month for multiple high-impact FDA reviews, spanning oncology, immunology, ophthalmology, and nephrology.
These decisions will shape the next generation of targeted and biologic therapies, addressing unmet clinical needs in SCLC, AML, CRSwNP, myopia, and lupus nephritis.
👉 Stay informed with DengYueMed for the latest global drug approvals and regulatory updates.
