MSD and LaNova Medicines Enter Exclusive Global License Agreement for Novel Cancer Therapy, LM-299

Promising CAR T Cell Therapies from BMS and Cabaletta Bio Show Potential for Durable Remission in Severe Lupus

FDA Grants Accelerated Approval to PTC Therapeutics' KEBILIDI™, the First Gene Therapy for AADC Deficiency in the U.S.

Association for Molecular Pathology Publishes Joint Consensus Report on SARS-CoV-2 Genomic Surveillance for Hospitals and Public Health Laboratories

Philips India Unveils Advanced Azurion Imaging System to Revolutionize Cardiac and Neurovascular Care

Tempus AI Study Highlights Benefits of Dual RNA and DNA Sequencing for Advanced Lung Cancer

Ontada and Datavant Partner to Expand Access to Real-World Oncology Data for Accelerated Cancer Innovation

Tempus AI and Flatiron Health Partner to Integrate Genomic Testing into OncoEMR for Enhanced Oncology Care

Flare Therapeutics and Roche Forge Strategic Partnership to Discover Precision Oncology Therapies Targeting Transcription Factors

FDA Approves Autolus’s CAR-T Therapy Aucatzyl for Relapsed or Refractory B-ALL in Adults

Biosimilars: Expanding Access to Precision Medicine through Affordable Biologic Therapies

IDEAYA Biosciences Secures Exclusive Worldwide License for Biocytogen’s BsADC Program IDE034 for Solid Tumor Treatment

Seer and Thermo Fisher Scientific Announce Strategic Collaboration to Advance Proteomics with Integrated Platform Solution

SystImmune Secures FDA Clearance for IND Application of Novel ADC Therapy BL-M17D1 for Advanced Solid Tumors

Medicare Expands Coverage for Adaptive Biotechnologies' clonoSEQ® MRD Test to Include Mantle Cell Lymphoma

Home
/
update
/
details

FDA Approves Roche's Tecentriq Hybreza, First Subcutaneous Anti-PD-(L)1 Cancer Immunotherapy

NextEdge Admin

14 Sep 2024

1 min 53 sec

Roche announced that the U.S. Food and Drug Administration (FDA) has approved Tecentriq Hybreza™ (atezolizumab and hyaluronidase-tqjs), the first PD-(L)1 inhibitor available as a subcutaneous (SC) injection for patients in the U.S. Tecentriq Hybreza can be administered under the skin in about seven minutes, compared to the 30-60 minutes needed for intravenous (IV) infusion of Tecentriq (atezolizumab). This new formulation is available for all IV-approved Tecentriq indications, including specific types of lung, liver, skin, and soft tissue cancers.

“Tecentriq Hybreza offers patients greater flexibility in cancer treatment administration,” said Dr. Levi Garraway, Roche’s Chief Medical Officer. He emphasized that this new formulation builds on the safety and efficacy of IV Tecentriq while offering faster and more convenient treatment.

The FDA's decision was based on data from the Phase IB/III IMscin001 study, which showed comparable drug levels and similar safety and efficacy between SC and IV forms. The Phase II IMscin002 study revealed that 71% of patients preferred the SC version due to less time in the clinic, greater comfort, and reduced emotional distress.

Tecentriq Hybreza has already been approved in 50 countries and continues to undergo regulatory reviews worldwide.