Drugs / MK-3475A
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | solid adenocarcinoma with mucin production | 2025-03-27 | “ペムブロリズマブ皮下注の生物製剤承認申請（BLA）を行い、米国食品医薬品局（FDA）に受理されました。” msd.co.jp ↗ |
| Filed | EU (EMA) | — | solid adenocarcinoma with mucin production | 2025-03-27 | “KEYTRUDA®の新剤形および新投与経路の適用拡大申請が欧州医薬品庁（EMA）に受理されました。” msd.co.jp ↗ |
Trials 0
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Comparator or background therapy1 trial | ||||||
| Phase 3 | NCT07431827 Background | Mar 2026 → Oct 2039 expected | non-small cell lung carcinoma | Merck Sharp & Dohme LLC | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Alteogen, Inc. | Regulatory 알테오젠 ALT-B4 적용 피하주사 제형 키트루다, 일본에서 판매 승인 획득 alteogen.com ↗
알테오젠(대표이사 전태연)은 자사의 피하주사(SC) 제형 변경 플랫폼 하이브로자임(Hybrozyme®)의 핵심 물질인 ALT-B4(성분명: 베라히알루로니다제 알파)가 적용된 MSD의 키트루다SC(일본 제품명: 키젝트, KEYJECT®)가 일본에서 제조 및 판매 승인을 획득했다고 18일 밝혔다. |
| 2026-07-10 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With Padcev® (enfortumab vedotin-ejfv), as Treatment Before and After Surgery for Adults With Muscle-Invasive Bladder Cancer (MIBC) merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev ® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). |
| 2026-06-12 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each With WELIREG® (belzutifan), for Adjuvant Treatment of Certain Patients With Clear Cell Renal Cell Carcinoma (ccRCC) merck.com ↗
These approvals represent the first approval for WELIREG in earlier-stage ccRCC and the first approvals for PD-1 and HIF-2α inhibitor combination regimens. |
| 2026-02-11 | Merck Sharp & Dohme LLC | Regulatory KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma as Second or Third Line Treatment merck.com ↗
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) plus paclitaxel, with or without bevacizumab, for the treatment of adults with PD-L1+ (Combined Positive Score [CPS] ≥1), as determined by an FDA-authorized test, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received one or two prior systemic treatment regimens. |
| 2025-11-21 | Merck Sharp & Dohme LLC | Regulatory FDA Approves KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Each with Padcev® (enfortumab vedotin-ejfv), as Perioperative Treatment for Adults with Cisplatin-Ineligible Muscle-Invasive Bladder Cancer merck.com ↗
These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population. |
| 2025-09-19 | Merck Sharp & Dohme LLC | Regulatory FDA Approves Merck’s KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) Injection for Subcutaneous Use in Adults Across Most Solid Tumor Indications for KEYTRUDA® (pembrolizumab) merck.com ↗ |
| 2025-04-25 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USAが開発するベラヒアルロニダーゼ アルファを配合したペムブロリズマブ皮下注製剤が3475A-D77試験でKEYTRUDA®点滴静注に対して薬物動態学的に非劣性を示す msd.co.jp ↗ |
| 2025-03-27 | Merck Sharp & Dohme LLC | Results Merck’s Investigational Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Demonstrates Noninferior Pharmacokinetics Compared to Intravenous (IV) KEYTRUDA® (pembrolizumab) in Pivotal 3475A-D77 Trial merck.com ↗ |
| 2024-12-11 | MSD R&D (China) Co., Ltd. | Results Merck & Co., Inc., Rahway, NJ, USA、Berahyaluronidase Alfaを配合したペムブロリズマブ皮下注製剤を用いた第3相試験で主要評価項目が達成されたことを発表 msd.co.jp ↗
この第3相試験では2つの薬物動態の主要評価項目を達成しました。 |
| 2024-11-19 | Merck Sharp & Dohme LLC | Results Merck Announces Phase 3 Trial of Subcutaneous Pembrolizumab With Berahyaluronidase Alfa Met Primary Endpoints merck.com ↗
The Phase 3 trial met its dual primary pharmacokinetic (PK) endpoints. |
All press releases naming this drug 10 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | MK-3475A | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07431827 ↗ |
| Route | Subcutaneous | “administered via SC injection” NCT07431827 ↗ |