Tecentriq Now FDA Approved for Treatment of Alveolar Soft-Part Sarcoma

JHOP - February 2023 Vol 13, No 1 - FDA Oncology Update

On December 9, 2022, the FDA approved atezolizumab (Tecentriq; Genentech), a PD-L1 inhibitor, for patients aged ≥2 years with unresectable or metastatic alveolar soft-part sarcoma (ASPS), a type of soft-tissue sarcoma. The FDA granted atezolizumab breakthrough therapy and orphan drug designations for this indication.

Atezolizumab was previously approved for many indications.

The approval of atezolizumab for ASPS was based on results of Study ML39345, an open-label, single-arm clinical trial of adult and pediatric patients with unresectable or metastatic ASPS. Eligible patients had histologically or cytologically confirmed unresectable ASPS. Patients were excluded if they had primary central nervous system (CNS) malignancy or symptomatic CNS metastases, liver disease, or a history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or active pneumonitis on imaging.

Of the 49 patients in the study, 47 were adults and 2 were pediatric patients (aged ≥12 years), with a median age of 31 years (range, 12-70 years). Adult patients received atezolizumab 1200 mg intravenously and pediatric patients received 15 mg/kg (up to a maximum of 1200 mg) intravenously once every 21 days, until disease progression or unacceptable adverse events.

The overall response rate was 24% (95% confidence interval, 13-39). Among the 12 patients who had an objective response, 67% had a response lasting ≥6 months, and 42% had a response lasting ≥12 months.

The most common (≥20%) adverse reactions were musculoskeletal pain (67%); fatigue (55%); rash (47%); cough (45%); nausea, headache, and hypertension (43% each); vomiting (37%); constipation and dyspnea (33% each); dizziness and hemorrhage (29% each); insomnia and diarrhea (27% each); pyrexia, anxiety, abdominal pain, and hypothyroidism (25% each); and decreased appetite and arrhythmia (22% each).

Related Items
FDA-Approved Nirogacestat Demonstrates Improved Patient Outcomes in Desmoid Tumor Management
Web Exclusives published on February 12, 2024 in FDA Oncology Update
Iwilfin FDA Approved for Adults and Pediatric Patients with High-Risk Neuroblastoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Welireg Now FDA Approved for Patients with Advanced Renal Cell Carcinoma
Web Exclusives published on January 17, 2024 in FDA Oncology Update
Keytruda Plus Chemotherapy Receives New FDA Approvals for Advanced Biliary Tract Cancer and 2 Forms of Advanced Gastroesophageal Junction Adenocarcinoma
Web Exclusives published on December 19, 2023 in FDA Oncology Update
FDA Approved Loqtorzi, a PD-1 Inhibitor, for the Treatment of Adults With Metastatic or Recurrent Nasopharyngeal Carcinoma
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Tibsovo FDA Approved for Patients With Relapsed Myelodysplastic Syndromes and IDH1 Mutation
Web Exclusives published on December 18, 2023 in FDA Oncology Update
Fruzaqla FDA Approved for Refractory Metastatic Colorectal Cancer
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
Rozlytrek Now Approved for Pediatric Patients Older Than 1 Month With Solid Tumors and NTRK Gene Fusion and in New Oral Pellet Form
JHOP - December 2023 Vol 13, No 6 published on December 6, 2023 in FDA Oncology Update
FDA Authorizes Updated COVID-19 Vaccine Formulations for Better Protection Against Current Variants
JHOP - December 2023 Vol 13, No 6 published on November 17, 2023 in FDA Oncology Update
Bosulif Now FDA Approved for Pediatric Patients With Chronic Myelogenous Leukemia
JHOP - December 2023 Vol 13, No 6 published on November 3, 2023 in FDA Oncology Update
© Amplity Health. All rights reserved.

Subscribe Today!

To sign up for our newsletter or print publications, please enter your contact information below.

I'd like to receive: