Onco-Summaries: Daily Oncology Updates at a Glance

19/02/2026

---

• Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer 

• Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC

• Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer

---

Enhertu's type II variation application has been validated by the EMA for HER2 +ve early Breast Cancer (Ref)

The EMA has validated the type II variation marketing authorization application for AstraZeneca & Daiichi Sankyo's ENHERTU® (trastuzumab deruxtecan; HER2 ADC) monotherapy for adult patients with HER2 +ve breast cancer who have residual invasive disease after neoadjuvant HER2 targeted treatment.

• The validation confirms the completion of the application and commences the scientific review process by the EMA’s CHMP

• The filing is based on data from the Phase 3 DESTINY-Breast05 trial presented at the 2025 ESMO Congress and subsequently published in The New England Journal of Medicine

Return to Top

Pilatus Biosciences' PLT012 received the FDA Fast Track designation for HCC (Ref)

The US FDA granted the Fast Track designation to Pilatus Biosciences' PLT012 (anti-CD36) for the treatment of hepatocellular carcinoma (HCC).

• Pilatus is also developing PLT012 in additional solid tumor indications.

• Raven Lin, Ph.D., Co-Founder and CEO, Pilatus Biosciences: “Receiving FDA Fast Track designation for PLT012 is an important milestone that reinforces the potential of our checkpoint therapy approach to transform the treatment of HCC. PLT012 was designed to address the metabolic adaptations that drive immune evasion in cancer. With IND clearance already secured and our Phase 1 trial open for patient enrollment, this designation will help accelerate clinical development and advance towards delivering a novel therapeutic option for patients, both in HCC and other solid tumors where patients do not benefit from existing immunotherapies.”

Return to Top

Genentech's NDA for giredestrant + everolimus has been accepted by the US FDA for certain patients with breast cancer (Ref)

The US FDA has accepted Genentech's NDA for giredestrant (estrogen receptor degrader and full antagonist) in combination with everolimus for the treatment of adult patients with ER+ve, HER2-ve, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen.

• The FDA is expected to make a decision on the approval by December 18, 2026

• The filing acceptance is based on the Phase III evERA Breast Cancer study results

Return to Top