Oncology Updates - Key Oncology News

December 2nd Week, 2025

Regulatory Events 

🎯 The US FDA granted approval to Johnson & Johnson Innovative Medicine's sNDA for niraparib and abiraterone acetate dual-action tablet (PARB inhibition and novel hormonal therapy) + prednisone for the treatment of patients with BRCA2-mutated metastatic castration-sensitive prostate cancer. (Ref 1)

❓ How is this approval expected to impact the treatment algorithm of the indication?

Clinical Events

🔬 The Phase 3 STAR-221 trial of Arcus Biosciences and Gilead Sciences' domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs nivolumab + chemotherapy as a first-line treatment for advanced gastric and esophageal cancers has been discontinued due to futility. (Ref 2)

❓ What are the possible reasons for failure of this TIGIT targeting strategy?

Special Designations

⭐ The US FDA granted priority review status to Bristol Myers Squibb's sBLA for nivolumab (anti-PD-1) + doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients with previously untreated stage III/IV classical Hodgkin Lymphoma. (Ref 3)

❓ How do the outcomes of this regimen compare against the current benchmarks?

⭐ The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to Senti Biosciences' SENTI-202 (logic gated off-the-shelf CAR-NK cell therapy) for the treatment of relapsed/refractory hematologic malignancies, including AML. (Ref 4)

❓ Which are the other key CAR-NK cell therapies being evaluated for this indication?

⭐ The US FDA granted the orphan drug designation to Ajax Therapeutics' AJ1-11095 (JAK2 inhibitor) for the treatment of myelofibrosis (Ref 5)

❓ What are the outcomes that supported the designation?

⭐ The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (Ref 6)

❓ What are the launch timeline estimates for this asset?

⭐ The US FDA granted the orphan drug designation to Chimeric Therapeutics' CHM CDH17 (CDH17-targeting CAR-T cell therapy) in the treatment of Gastric Cancer (Ref 7)

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

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

🌐 References:

1) https://www.jnj.com/media-center/press-releases/u-s-fda-approves-akeega-as-the-first-precision-therapy-for-brca2-mutated-metastatic-castration-sensitive-prostate-cancer-with-54-reduction-in-disease-progression-vs-standard-of-care

2) https://investors.arcusbio.com/investors-and-media/press-releases/press-release-details/2025/Arcus-Provides-Update-on-Phase-3-STAR-221-Study-and-Concentrates-Its-RD-Investment-on-Casdatifan-and-Emerging-Inflammation-and-Immunology-Portfolio/default.aspx

3) https://news.bms.com/news/details/2025/U-S--Food-and-Drug-Administration-FDA-Grants-Priority-Review-to-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-Plus-Chemotherapy-Combination-for-Classical-Hodgkin-Lymphoma/default.aspx

4) https://investors.sentibio.com/news-releases/news-release-details/senti-bio-receives-fda-regenerative-medicine-advanced-therapy

5) https://www.biospace.com/press-releases/ajax-therapeutics-receives-orphan-drug-designation-from-the-u-s-fda-for-aj1-11095-for-the-treatment-of-myelofibrosis

6) https://www.gsk.com/en-gb/media/press-releases/gsk-227-a-b7-h3-targeted-antibody-drug-conjugate-granted-orphan-drug-designation-in-small-cell-lung-cancer-by-the-us-fda/

7) https://app.sharelinktechnologies.com/announcement-preview/asx/32972ad6a594560ea987f0dcb830ea18