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11/12/2021

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FDA Approval
FDA Approves Vepdegestrant for Patients With ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
05/01/2026
Emily Estrada
Based on results from the phase 3 VERITAC-2 trial, the FDA has approved vepdegestrant for patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Based on results from the phase 3 VERITAC-2 trial, the FDA has approved vepdegestrant for patients with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Based on results from the phase...
05/01/2026
Oncology
News
Varegacestat Advances Toward FDA Review in Desmoid Tumors
04/30/2026
Stephanie Holland
Based on results from the phase 3 RINGSIDE trial, a New Drug Application for varegacestat has been submitted to the FDA for the treatment of adult patients with desmoid tumors.
Based on results from the phase 3 RINGSIDE trial, a New Drug Application for varegacestat has been submitted to the FDA for the treatment of adult patients with desmoid tumors.
Based on results from the phase...
04/30/2026
Oncology
News
Nirogacestat Improves Outcomes Across Prognostic Subgroups of Patients With Desmoid Tumors
04/30/2026
Stephanie Holland
Results from a post hoc analysis of the phase 3 DeFi trial demonstrate that nirogacestat provides consistent clinical benefit across prognostic subgroups of patients with desmoid tumors.
Results from a post hoc analysis of the phase 3 DeFi trial demonstrate that nirogacestat provides consistent clinical benefit across prognostic subgroups of patients with desmoid tumors.
Results from a post hoc analysis...
04/30/2026
Oncology
News
FOG-001 Shows Early Activity in Patients With Desmoid Tumors
04/30/2026
Stephanie Holland
Results from a phase 1/2 study demonstrate that FOG-001 shows early clinical activity with manageable safety in patients with desmoid tumors.
Results from a phase 1/2 study demonstrate that FOG-001 shows early clinical activity with manageable safety in patients with desmoid tumors.
Results from a phase 1/2 study...
04/30/2026
Oncology
News
Bireociclib Plus Fulvestrant in HR-Positive, HER2-Negative Advanced Breast Cancer
04/30/2026
Emily Estrada
Final results from the phase 3 BRIGHT-2 trial demonstrated that bireociclib plus fulvestrant significantly improves PFS compared with fulvestrant alone in previously treated HR-positive, HER2-negative advanced breast cancer.
Final results from the phase 3 BRIGHT-2 trial demonstrated that bireociclib plus fulvestrant significantly improves PFS compared with fulvestrant alone in previously treated HR-positive, HER2-negative advanced breast cancer.
Final results from the phase 3...
04/30/2026
Oncology
News
Romiplostim Reduces the Need for Dose Modifications in Chemotherapy-Induced Thrombocytopenia
04/30/2026
Emily Estrada
Results from the phase 3 RECITE trial demonstrated that romiplostim significantly reduced the need for chemotherapy dose modifications in patients with chemotherapy-induced thrombocytopenia.
Results from the phase 3 RECITE trial demonstrated that romiplostim significantly reduced the need for chemotherapy dose modifications in patients with chemotherapy-induced thrombocytopenia.
Results from the phase 3 RECITE...
04/30/2026
Oncology
News
Tri-Weekly Cisplatin Matches Weekly Dosing With Better Tolerability in Cervical Cancer
04/30/2026
Stephanie Holland
Results from the phase 3 TACO trial demonstrate that tri-weekly cisplatin provides similar survival with improved safety and quality of life vs weekly dosing in patients with locally advanced cervical cancer.
Results from the phase 3 TACO trial demonstrate that tri-weekly cisplatin provides similar survival with improved safety and quality of life vs weekly dosing in patients with locally advanced cervical cancer.
Results from the phase 3 TACO...
04/30/2026
Oncology
FDA Alerts
FDA Grants Breakthrough Therapy Designation to TERN-701 in Ph-Positive Chronic Myeloid Leukemia
04/30/2026
Stephanie Holland
Based on data from the phase 1/2 CARDINAL study, the FDA has granted breakthrough therapy designation to TERN-701 for previously treated Ph-positive chronic myeloid leukemia.
Based on data from the phase 1/2 CARDINAL study, the FDA has granted breakthrough therapy designation to TERN-701 for previously treated Ph-positive chronic myeloid leukemia.
Based on data from the phase 1/2...
04/30/2026
Oncology
News
HSK42360 Shows Clinical Promise in BRAF V600-Mutant Glioma
04/29/2026
Emily Estrada
Results from a phase 1 study demonstrate that HSK42360 shows promising clinical activity with favorable safety in patients with BRAF V600-mutant gliomas.
Results from a phase 1 study demonstrate that HSK42360 shows promising clinical activity with favorable safety in patients with BRAF V600-mutant gliomas.
Results from a phase 1 study...
04/29/2026
Oncology
News
G-CSF Supports Effective Docetaxel Delivery in Metastatic Hormone-Sensitive Prostate Cancer
04/29/2026
Emily Estrada
Post hoc analysis results from the phase 3 ARASENS trial demonstrate that early G-CSF use and appropriate dose modifications allow most patients with metastatic hormone-sensitive prostate cancer to maintain effective docetaxel dosing with...
Post hoc analysis results from the phase 3 ARASENS trial demonstrate that early G-CSF use and appropriate dose modifications allow most patients with metastatic hormone-sensitive prostate cancer to maintain effective docetaxel dosing with...
Post hoc analysis results from...
04/29/2026
Oncology

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