FDA ACCELERATED APPROVAL16 Apr 2025 19:54
Note: Avacta uses wording Clinically Meaningful and Unmet Need which is the same as the FDA requirement....clues perhaps that something might be forthcoming if Avacta can come up with a Surrogate Endpoint....data, data, data!!!!!
'16 Jan 2025...Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers
Meaningful tumor shrinkage observed in five out of 10 patients with partial and minor responses and 90% disease control rate in patients with salivary gland cancers
Phase 1b expansion cohorts screening patients in triple negative breast cancer, soft tissue sarcoma and salivary gland cancer'
and from 07 Mar 2025
Alan Ho, MD PhD, Chief of the Head and Neck Oncology Service, Memorial Sloan Kettering Cancer Center and member, Avacta Scientific Advisory Board, commented:
“We are very excited to move the development of AVA6000 to the next level to generate data that demonstrates clinically meaningful efficacy and durability of response in patients with previously treated salivary gland cancers. It is important to note the high degree of unmet need in this disease where few agents have shown efficacy. I am happy to participate in the trials of AVA6000 in this disease setting going forward.”
Christina Coughlin, CEO of Avacta Therapeutics commented: “We are very pleased to advance to the expansion cohorts in the AVA6000 trial in these three indications with high unmet need. Our development of AVA6000 is proceeding according to plans and today’s new data demonstrate the durability of the responses we have observed in the SGC indication. We believe that AVA6000 has an important role to play in the clinic, given our preliminary efficacy data and the large commercial market size of conventional doxorubicin”
and the 'FDA Accelerated Approval says...
When studying a new drug, it can sometimes take many years to learn whether a drug actually provides a real effect on how a patient survives, feels, or functions. A positive therapeutic effect that is clinically meaningful in the context of a given disease is known as “clinical benefit”. Mindful of the fact that it may take an extended period of time to measure a drug’s intended clinical benefit, in 1992 FDA instituted the Accelerated Approval regulations. These regulations allowed drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint. Using a surrogate endpoint enabled the FDA to approve these drugs faster.'
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/accelerated-approval
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