Oncology Updates - Key Oncology News

December 1st Week, 2025

Regulatory Events

🎯 The US FDA granted approval to Eli Lilly and Company's pirtobrutinib (BTK inhibitor) for the treatment of adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. (Ref 1)

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

🎯 The US FDA granted approval to Bristol Myers Squibb's lisocabtagene maraleucel (CD19-directed CAR-T cell therapy) for the treatment of adult patients with R/R marginal zone lymphoma who have received at least two prior lines of systemic therapy. (Ref 2)

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

🎯 The EMA validated for review, a Type II variation application for Astellas Pharma and Pfizer's enfortumab vedotin (Nectin-4 directed ADC) + pembrolizumab as a neoadjuvant treatment, and then continued after radical cystectomy as adjuvant treatment, for adults with MIBC who are ineligible for cisplatin-containing chemotherapy. (Ref 3)

❓ What were the clinical outcomes that supported this filing?

Clinical Events

🔬 The Phase 3 BRUIN CLL-314 trial of Eli Lilly and Company's pirtobrutinib (BTK inhibitor) met its primary endpoint of non-inferiority on ORR vs ibrutinib in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who were treatment-naïve or were BTK inhibitor-naïve. (Ref 4)

❓ What are the launch timeline estimates for this asset?

Special Designations

⭐ The US FDA granted the fast track designation to Cullinan Therapeutics' CLN-049 (FLT3 x CD3 bispecific T cell engager) for the treatment of relapsed/refractory acute myeloid leukemia. (Ref 5)

❓ Which are the other key bispecific assets being evaluated for this indication?

⭐ The US FDA granted the orphan drug designation to J & D Pharmaceuticals' investigational therapy for the treatment of Hepatocellular Carcinoma. (Ref 6)

❓ 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://investor.lilly.com/news-releases/news-release-details/us-fda-approves-expanded-indication-lillys-jaypirca

2) https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibbs-Breyanzi-Approved-by-the-U-S--FDA-as-the-First-and-Only-CAR-T-Cell-Therapy-for-Adults-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma-MZL/default.aspx

3) https://newsroom.astellas.com/2025-12-1-European-Medicines-Agency-Validates-Type-II-Variation-Application-for-PADCEVTM-enfortumab-vedotin-with-KEYTRUDATM-pembrolizumab-for-Certain-Patients-with-Muscle-Invasive-Bladder-Cancer

4) https://investor.lilly.com/news-releases/news-release-details/lillys-jaypirca-pirtobrutinib-met-its-primary-endpoint-first-its

5) https://www.globenewswire.com/news-release/2025/12/01/3196843/0/en/Cullinan-Therapeutics-Receives-FDA-Fast-Track-Designation-for-CLN-049-a-Novel-FLT3xCD3-T-Cell-Engager-in-Relapsed-Refractory-Acute-Myeloid-Leukemia.html

6) https://www.prnewswire.com/news-releases/j--d-pharmaceuticals-llc-receives-orphan-drug-designation-for-treatment-of-hepatocellular-carcinoma-hcc-302632020.html