Onco-Summaries: Daily Oncology Updates at a Glance

15/12/2025

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• Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer

• FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes

  
  

• Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program

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Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan + pertuzumab has been approved for first-line HER2+ve breast cancer (Ref)

The US FDA granted approval to Daiichi Sankyo and AstraZeneca's trastuzumab deruxtecan (ENHERTU; HER2 ADC) in combination with pertuzumab as a first-line treatment for adult patients with unresectable or metastatic HER2 +ve breast cancer.

• The approval has been granted based on results from the Phase 3 DESTINY-Breast09 trial

• The FDA completed the review under the Real Time Oncology Review (RTOR) program, following Priority Review and Breakthrough Therapy Designation status of the regimen

• To note, ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity

FibroGen's roxadustat received the FDA Orphan Drug Designation for myelodysplastic syndromes (Ref)

The US FDA granted the orphan drug designation to FibroGen's roxadustat (HIF-PH inhibitor) for the treatment of myelodysplastic syndromes (MDS).

• Thane Wettig, CEO, FibroGen: “The Orphan Drug Designation granted to roxadustat for MDS underscores the significant treatment gap in this indication, and highlights patients’ need for additional convenient treatments that can provide durable response. Roxadustat showed an improvement in transfusion-independence in a subset of patients with high transfusion burden in a post-hoc analysis from the Phase 3 MATTHERHORN trial, which along with its favorable tolerability profile and oral route of administration has the ability to set it apart from current second-line treatments. Our team is finalizing the Phase 3 protocol in this patient population for submission to the FDA in the fourth quarter of 2025.”

Eli Lilly's TECVAYLI plus DARZALEX FASPRO combo has been selected for the FDA's CNPV Pilot program (Ref)

The US FDA selected Eli Lilly's sBLA for teclistamab (BCMA x CD3 BsAb) regimen in multiple myeloma to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program as it aligns with the program’s priority to deliver more innovative therapies for American people.

• The sBLA is based on results from the Phase 3 MajesTEC-3 trial, in which teclistamab + daratumumab and hyaluronidase-fihj demonstrated a statistically significant PFS and OS benefit vs SOC in patients with relapsed/refractory multiple myeloma