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

• Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC

• Amtagvi® (lifileucel) wins conditional TGA approval as Australia’s first T‑cell therapy for advanced melanoma, expanding Iovance’s global footprint

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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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Verastem’s VS-7375 secures FDA Fast Track for KRAS G12D-mutated NSCLC (Ref)

Verastem’s VS-7375, an oral investigational KRAS G12D (ON/OFF) inhibitor, received Fast Track Designation for KRAS G12D-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior platinum chemotherapy and anti-PD-(L)1 therapy

Clinical program:

• TARGET-D 101 (Phase 1/2): Ongoing dose escalation/expansion trial across KRAS G12D-mutated solid tumors (pancreatic, NSCLC, colorectal). Early data show VS-7375 is well tolerated, with no major safety concerns to date

• TARGET-D 202 (Phase 2): Registration-directed trial in 2L/3L advanced NSCLC, including patients with untreated brain metastases

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Amtagvi® (lifileucel) wins conditional TGA approval as Australia’s first T‑cell therapy for advanced melanoma, expanding Iovance’s global footprint (Ref)

Australia’s Therapeutic Goods Administration (TGA) has conditionally approved Iovance Biotherapeutics' Amtagvi® (lifileucel), making it the first T cell therapy for a solid tumor and the first treatment option in Australia for advanced melanoma after anti‑PD‑1 and targeted therapy

Indication: Approved for adult patients with unresectable or metastatic melanoma who have previously received PD‑1 blockade, and if BRAF V600 mutation positive, a BRAF inhibitor ± MEK inhibitor

Approval was supported by results from the global Phase 2 C‑144‑01 trial, which showed efficacy in previously treated advanced melanoma

Iovance is also running the Phase 3 TILVANCE‑301 trial in frontline advanced melanoma and expanding Amtagvi into other solid tumors

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