Oncology Updates - Key Oncology News

September 3rd Week, 2025

Regulatory Events

🎯 The US FDA approved Merck & Co/MSD’s Keytruda Qlex (subcutaneous injection of pembrolizumab and berahyaluronidase alfa) in adults across most solid tumor indications for Keytruda. (Ref 1)

❓ How is this SC injection positioned against other approved SC anti-PD(L)1s?

🎯 Japan’s Ministry of Health, Labour and Welfare approved Novocure's Optune Lua (tumor treating fields) for concurrent use with PD-1/PD-L1 inhibitors for the Tx of adults with unresectable advanced/recurrent NSCLC who have progressed on or after platinum-based chemo. (Ref 2)

❓ How is the approval expected to impact the Tx paradigm in Japan?

🎯 Replimune completed a Type A meeting with the US FDA discussing the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivo for the Tx of advanced melanoma. (Ref 3)

❓ What are the potential next steps in the development of RP1?

Special Designations

⭐ The US FDA granted the Breakthrough Therapy Designation to Daiichi Sankyo and Merck & Co./MSD's raludotatug deruxtecan (CDH6-directed ADC) for the Tx of adults with platinum-resistant epithelial ovarian, primary peritoneal or fallopian tube cancers expressing CDH6 who have received prior Tx with bevacizumab. (Ref 4)

❓ What are the key pros and cons associated with this ADC?

⭐ The US FDA granted the Fast Track Designation to Corbus Pharmaceuticals and CSPC Pharmaceutical Group 's CRB-701 (Nectin-4 targeting ADC) for the Tx of R/M HNSCC previously treated with platinum-based chemo and an anti-PD(L)-1. (Ref 5)

❓ Which other ADCs have received the designation in this indication?

⭐ The US FDA granted the Fast Track Designation to Minovia Therapeutics ' MNV-201 (cell therapy utilizing Mitochondrial Augmentation Technology) for Myelodysplastic Syndrome. (Ref 6)

❓ What were the outcomes that supported the designation?

⭐ The US FDA granted the Orphan Drug Designation to Akeso Biopharma's ligufalimab (AK117; anti-CD47) for the Tx of acute myeloid leukemia. (Ref 7)

❓ What are the other key assets in pipeline for the Tx of AML?

⭐ The US FDA granted the Orphan Drug Designation to Rgenta Therapeutics Inc.'s RGT-61159 (small molecule inhibitor of MYB) for the Tx of adenoid cystic carcinoma. (Ref 8)

❓ What are the key unmet medical needs for this indication?

To know answers to these questions and for additional insights, write to us at support@oncofocus.com.

🌐 References:

1) https://www.merck.com/news/fda-approves-mercks-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-injection-for-subcutaneous-use-in-adults-across-most-solid-tumor-indications-for-keytruda-pem/

2) https://www.novocure.com/novocures-optune-luar-receives-approval-japan-treatment-unresectable-advancedrecurrent-non-small

3) https://ir.replimune.com/news-releases/news-release-details/replimune-provides-update-following-type-meeting-fda

4) https://www.merck.com/news/raludotatug-deruxtecan-granted-breakthrough-therapy-designation-by-u-s-fda-for-patients-with-cdh6-expressing-platinum-resistant-ovarian-primary-peritoneal-or-fallopian-tube-cancers-previously-treat/

5) https://ir.corbuspharma.com/news-events/press-releases/detail/448/fda-grants-fast-track-designation-to-corbus-pharmaceuticals-nectin-4-targeting-adc-crb-701-in-head-and-neck-squamous-cell-carcinoma

6) https://finance.yahoo.com/news/minovia-therapeutics-receives-fda-fast-113000661.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cubGlua2VkaW4uY29tLw&guce_referrer_sig=AQAAAIsVBibhDgJWZ5g5L_IvevhsiFXZH9gbFRhHOkCFgGyft-lXITZVrMuXlnFGawFOX8JTbeLQf-Rc0UPLr3srvrIS3ulZcAWnZY49XH0yjTLsyiqig4WnqM0lhuRwYC4kb8Pwz5SWrY9E3hkeK-nnuKUTnaDCpu58HBaJ9YDIy447

7) https://www.akesobio.com/en/media/akeso-news/250916/

8) https://www.globenewswire.com/news-release/2025/09/17/3151594/0/en/Rgenta-Therapeutics-Receives-Orphan-Drug-Designation-from-the-U-S-FDA-for-RGT-61159-for-the-Treatment-of-Adenoid-Cystic-Carcinoma-ACC.html