Expedited Review Pathway Drugs — April 2026
Expedited Review Pathway
Drugs — April 2026
In April 2026, 101 drugs received expedited review pathway designations worldwide across 13 distinct pathways, led by Orphan Drug (37), Fast Track (22), Priority Review (16), and Breakthrough Therapy (11). Notable designations include TERN-701 (Bcr-Abl, CML), Risvutatug Rezetecan (ADC, CRPC), Plixorafenib (BRAF, glioblastoma), and Raguneprocel (iPSC, Parkinson disease).
101 ERP designations across 13 pathways — April 2026
Source: April 2026 monthly report, Para 52 and Table 2.
11 Breakthrough Therapy designations — April 2026
All 11 BTDs from Table 2, rows 3–13 of the April 2026 monthly report.
| Drug | Target | Indication | Developer | Region · Date |
|---|---|---|---|---|
| Pegylated bovine carboxyhemoglobin | — | Acute Ischemic Stroke | Prolong Pharmaceuticals LLC | US · Apr 30 |
| Gamgertamig | BCMA · CD3 | Immunoglobulin Light-Chain Amyloidosis | Keymed Biomedical Technology (Chengdu) | China · Apr 28 |
| IBI-363 | PD-1 · IL2RA | MSS/pMMR/MSI-L Colorectal Carcinoma | Innovent Biologics (Suzhou) | China · Apr 28 |
| NHWD-870 | BRD4 | Advanced NUT Carcinoma | Hunan Hengya Pharmaceutical Technology; Ningbo Wenda Pharmaceutical Technology | China · Apr 28 |
| TERN-701 | Bcr-Abl | Philadelphia chromosome-positive CML in chronic phase | Terns Pharmaceuticals, Inc. | US · Apr 27 |
| Risvutatug Rezetecan | Top I · CD276 | Castration-Resistant Prostatic Cancer | Shanghai Hansoh Biomedical Co. Ltd. | China · Apr 21 |
| VGA-039 | PROS1 | Von Willebrand Diseases | Star Therapeutics, Inc. | US · Apr 21 |
| Trastuzumab Rezetecan | Top I · HER2 | HER2 Positive Breast Cancer | Suzhou Suncadia Biopharmaceuticals | China · Apr 9 |
| SHR-A2102 | nectin-4 · Top I | Metastatic Cervical Carcinoma; Recurrent Cervical Cancer | Shanghai Hengrui Pharmaceutical | China · Apr 8 |
| Pembrolizumab / Hyaluronidase | PD-1 · Hyaluronic acid | Locally Advanced NSCLC; Metastatic NSCLC | MSD R&D (China) Co. Ltd. | China · Apr 8 |
| Plixorafenib | BRAF | Glioblastoma Harboring BRAF V600 Mutation | Fore Biotherapeutics, Inc. | US · Apr 7 |
5 Conditional Marketing Approvals — April 2026
Spanning China, EU, and Japan across EGFR/HER2 NSCLC, glioma, Parkinson disease, and SCLC. Source: Table 2.
| Drug | Target | Indication | Developer | Region · Date |
|---|---|---|---|---|
| Andamertinib | EGFR | EGFR ex20ins mutation NSCLC | Avistone (Ningbo) Biotechnology | China · Apr 30 |
| Tovorafenib | PDPK1 · Raf kinase | BRAF fusion/rearrangement or V600 mutation low-grade glioma | Ipsen Pharma SAS | EU · Apr 22 |
| Raguneprocel | — | Parkinson Disease | Sumitomo Pharma Co., Ltd. | Japan · Apr 17 |
| Sevabertinib | EGFR exon 20 · HER2 exon 20 · EGFR C797S | HER2 mutant NSCLC | Bayer HealthCare Pharmaceuticals | China · Apr 14 |
| TARLATAMAB-DLLE | CD3 · DLL3 | Extensive stage Small Cell Lung Cancer | BeOne Medicines (Beijing) | China · Apr 7 |
4 signals from the April 2026 ERP data
Strategic takeaways from 101 ERP designations in the April 2026 monthly report.
3 ADCs among April 2026 BTDs — CD276, HER2, nectin-4 all Top I-paired
Three of the 11 April 2026 Breakthrough Therapy designations are ADCs: Risvutatug Rezetecan (Top I/CD276, CRPC, Hansoh), Trastuzumab Rezetecan (Top I/HER2, HER2+ breast, Suncadia), and SHR-A2102 (nectin-4/Top I, cervical cancer, Hengrui). All three pair a tumour antigen with a Top I payload — continuing the April BTD cohort’s heavy weighting toward Top I-conjugated ADCs seen across this month’s data.
Raguneprocel: first iPSC therapy CMA for Parkinson disease in Japan
Raguneprocel received Conditional Marketing Approval from Japan’s PMDA on April 17, 2026 for Parkinson Disease, developed by Sumitomo Pharma Co., Ltd. As an induced pluripotent stem cell (iPSC) therapy, this designation marks a significant milestone in Japan’s regenerative medicine regulatory pathway — extending iPSC-derived cell therapy approval into a major neurodegenerative disease indication.
Psilocybin earns Commissioner’s National Priority Voucher for treatment-resistant depression
Psilocybin (5-HT6, 5-HT2A, 5-HT2C, 5-HT1A receptor; Compass Pathways) received a Commissioner’s National Priority Voucher designation in the US on April 24, 2026 for Treatment-Resistant Depressive Disorder — one of the rarer ERP pathway types. CNPV is a FDA mechanism providing priority review voucher incentives, reflecting continued regulatory engagement with psychedelic-assisted therapy development in treatment-resistant depression.
China leads April 2026 ERP activity: 7 of 11 BTDs and 4 of 5 CMAs
China’s NMPA granted 7 of the 11 April 2026 Breakthrough Therapy designations — Gamgertamig, IBI-363, NHWD-870, Risvutatug Rezetecan, Trastuzumab Rezetecan, SHR-A2102, and Pembrolizumab/Hyaluronidase — and 4 of the 5 CMAs (Andamertinib, Sevabertinib, TARLATAMAB-DLLE, plus Raguneprocel in Japan). China also held 8 of the 16 Priority Review designations, spanning oncology, antiviral, and cardiometabolic indications.
April 2026 expedited review pathway drugs — key questions
In April 2026, there were 101 drugs under Expedited Review pathways worldwide, including 37 Orphan Drug, 2 Rare Pediatric Disease, 11 Breakthrough Therapy, 22 Fast Track, 16 Priority Review, 5 Conditional Marketing Approval, 3 Regenerative Medicine Advanced Therapy, 1 Accelerated Approval, 1 Advanced Therapy Medicinal Products, 1 Commissioner’s National Priority Voucher, 1 Innovative Licensing and Access Pathway, 1 PRIME, and 1 Qualified Infectious Disease Product.
11 Breakthrough Therapy designations were granted in April 2026, including TERN-701 (Bcr-Abl, CP-CML), Risvutatug Rezetecan (Top I/CD276, CRPC), Trastuzumab Rezetecan (Top I/HER2, HER2+ breast cancer), SHR-A2102 (nectin-4/Top I, cervical cancer), Gamgertamig (BCMA/CD3, AL amyloidosis), IBI-363 (PD-1/IL2RA, CRC), NHWD-870 (BRD4, NUT carcinoma), Plixorafenib (BRAF, glioblastoma), Pegylated bovine carboxyhemoglobin (stroke), Pembrolizumab/Hyaluronidase (PD-1, NSCLC), and VGA-039 (PROS1, von Willebrand disease).
Orphan Drug had the most ERP designations in April 2026, with 37 drugs receiving this designation.
5 Conditional Marketing Approvals were granted in April 2026: Andamertinib (EGFR ex20ins, NSCLC, China), Tovorafenib (BRAF, low-grade glioma, EU), Raguneprocel (iPSC, Parkinson Disease, Japan), Sevabertinib (EGFR/HER2 exon 20, NSCLC, China), and TARLATAMAB-DLLE (CD3/DLL3, SCLC, China).
Less common pathways appearing in April 2026 ERP designations include: Commissioner’s National Priority Voucher (CNPV, Psilocybin, treatment-resistant depression, US), Innovative Licensing and Access Pathway (ILAP, SGSH gene therapy, UK), PRIME (RTx-015, retinitis pigmentosa, EU), and Qualified Infectious Disease Product (QIDP, ISHA-004, oropharyngeal candidiasis, US).
Data on this page is sourced from the PatSnap April 2026 monthly pharmaceutical report, Para 52 and Table 2 (ERP designations). Represents a snapshot of available records as of April 2026.