Oncology Updates - Key Oncology News
September 1st Week, 2026
Regulatory Events
🎯 The US FDA granted an accelerated approval to AstraZeneca's camizestrant (Etcamah; SERD and complete ER antagonist) + a CDK4/6 inhibitor for the 1L Tx of HR+/HER2- ESR1-mutated LA/M breast cancer (Ref1)
❓ What is the addressable market size for Etcamah in the US?
🎯 AstraZeneca and Daiichi Sankyo' trastuzumab deruxtecan (Enhertu; HER2 ADC) + pertuzumab (anti-HER2) has secured EU approval as 1L Tx for HER2+ unresectable or metastatic breast cancer (Ref2)
❓ How is Enhertu positioned in the EU breast cancer market landscape?
🎯 The US FDA approved PharmaEssentia’s ropeginterferon alfa-2b-njft (BESREMi; long-acting interferon-based therapy) for Tx of adults with essential thrombocythemia (ET) (Ref3)
❓ How is this approval expected to impact the ET Tx paradigm?
🎯 Karyopharm Therapeutics Inc. filed an sNDA for selinexor (Xpovio; XPO1 inhibitor) + ruxolitinib (JAK1/2 inhibitor) in myelofibrosis under the US FDA Accelerated Approval pathway (Ref4)
❓ What is the expected approval timeline for selinexor in myelofibrosis?
Special Designation
⭐ The US FDA granted Fast Track Designation to T-MAXIMUM PHARMACEUTICAL's MT027 (allo B7-H3 CAR-T) for the Tx of recurrent glioblastoma (Ref5)
❓ How is MT027 positioned in the glioblastoma developmental landscape?
Clinical Updates
🔬 Summit Therapeutics, Inc. and Akeso Biopharma’s ivonescimab (PD-1 x VEGF BsAb) demonstrated a statistically significant OS benefit vs MSD’s pembrolizumab in 1L PD‑L1+ LA/M NSCLC in China (Ref6)
❓ How is ivonescimab positioned in the China NSCLC market landscape?
🔬 AbbVie's etentamig (BCMA x CD3 bispecific TCE) significantly improved ORR and PFS in R/R multiple myeloma, with IDMC recommending study unblinding (Ref7)
❓ What is the current SOC for R/R multiple myeloma?
🔬 PMV Pharmaceuticals, Inc.' rezatapopt (p53 reactivator) delivered a 46% interim ORR in the ovarian cancer cohort of the pivotal Ph2 PYNNACLE trial in TP53 Y220C advanced solid tumors (Ref8)
❓ What are the clinical benchmarks for ovarian cancer Tx?
🔬 HUTCHMED and AZ’s savolitinib (Orpathys; MET TKI) + AstraZeneca's osimertinib (Tagrisso; EGFR TKI) demonstrated significant PFS benefit with early OS signal in 1L EGFRm NSCLC with MET overexpression in China (Ref9)
❓ How many MET-directed agents are currently being developed for NSCLC?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
header.all-comments