Onco-Summaries: Daily Oncology Updates at a Glance

03/06/2026

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• Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer

  
  

• FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26

• Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity

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Terremoto Biosciences Secures FDA Fast Track for AKT1‑Selective Inhibitor TER‑2013 in HR+/HER2– Breast Cancer (Ref)

Terremoto's TER-2013 has received Fast Track status for HR+/HER2– breast cancer with AKT1/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease

Preclinical Strength: Demonstrated potent, sustained AKT1 inhibition with durable anti-tumor activity across xenograft models with PIK3CA, AKT1, or PTEN alterations

TER-2013 is being evaluated in a Phase 1 first-in-human study (NCT-07109726) in solid tumors with AKT/PI3K/PTEN pathway alterations

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FDA grants Orphan Drug Designation to Sotio’s LRRC15-targeted ADC SOT106 for osteosarcoma, advancing toward first-in-human trial in 2H26 (Ref)

SOTIO Biotech's SOT106 has received U.S. FDA Orphan Drug Designation for osteosarcoma, highlighting its potential as a targeted therapy for a rare, high unmet need cancer population

First-in-human trial planned for the second half of 2026

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Lupin & Natco secure FDA approval for Eribulin generic, unlocking $43.7M U.S. market opportunity (Ref)

Lupin and Natco Pharma received U.S. FDA approval for Natco’s Abbreviated New Drug Application (ANDA) for Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) single-dose vials

The product is bioequivalent to Halaven® Injection from Eisai

Indications: Approved for treatment of:

• Adults with metastatic breast cancer who have received at least two prior chemotherapeutic regimens.

• Patients with unresectable or metastatic liposarcoma who have received an anthracycline-containing regimen

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