The US Food and Drug Administration (FDA) has granted Roche (SWX: ROG) Breakthrough Therapy Designation for Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) as first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver cancer, the multinational pharmaceutical company disclosed on Wednesday.
This designation was based on data from a Phase Ib study assessing the safety and clinical activity of the combination of Tecentriq and Avastin. Data from the study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting which took place in June.
The data revealed that, after a median follow-up of 10.3 months, responses were seen in 15 (65%) of 23 efficacy-evaluable patients. Median progression-free survival, duration of response, time to progression, and overall survival were not reached after a median follow-up of 10.3 months. No new safety signals were identified beyond the established safety profiles for the individual medicines.
Breakthrough Therapy Designation is designed to speed up the development and review of medicines to treat serious or life-threatening diseases. It also helps provide patients with access to the medicines via FDA approval as soon as possible.
This latest Breakthrough Therapy Designation is the 22nd for Roche's portfolio of medicines and the third for Tecentriq.
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial