Theralase Technologies Inc. V.TLT

Alternate Symbol(s): TLTFF

Healthcare Medical Devices

Theralase Technologies Inc. is a Canada-based clinical-stage pharmaceutical company. The Company is engaged in the research and development of light activated compounds and their associated drug formulations. The Company operates through two divisions: Anti-Cancer Therapy (ACT) and Cool Laser Therapy (CLT). The Anti-Cancer Therapy division develops patented, and patent pending drugs, called Photo Dynamic Compounds (PDCs) and activates them with patent pending laser technology to destroy specifically targeted cancers, bacteria and viruses. The CLT division is responsible for the Company’s medical laser business. The Cool Laser Therapy division designs, develops, manufactures and markets super-pulsed laser technology indicated for the healing of chronic knee pain. The technology has been used off-label for healing numerous nerve, muscle and joint conditions. The Company develops products both internally and using the assistance of specialist external resources.

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Theralase Technologies Inc. > FDA Pre-Breakthrough Therapy Designation Advice

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Comment by DeathXray33on Jan 24, 2024 1:20pm

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Post# 35843318

RE:FDA Pre-Breakthrough Therapy Designation Advice

Eoganacht wrote: I found some interesting infornation online about pre-BTD application advice. This is from the FDA's website:

Frequently Asked Questions: Breakthrough Therapies

"Can a sponsor get preliminary breakthrough therapy designation (BTD) advice from the review division prior to the submission of a formal BTD request?

A sponsor can contact the regulatory project manager (RPM) in the division to which the active IND is assigned and request the “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template. This template should then be submitted as a formal amendment to the IND and a subsequent teleconference between the sponsor and the review division will be set-up by the RPM. The review division will make a recommendation as to whether a request for a BTD is appropriate, may be too preliminary, or does not currently meet the criteria for a BTD. The Agency’s recommendation is advisory and is not to be interpreted to predict the Agency’s decision on the BTD request. NOTE: A Preliminary BTD Advice Request may be submitted to an active PIND, although a formal BTD request may not be submitted until the IND is opened."

Here is a blank “Preliminary Breakthrough Therapy Designation (BTD) Advice Request” template:

https://www.ipqpubs.com/wp-content/uploads/2016/03/Preliminary-BTDR-Advice-Template.pdf

What I found even more interesting was an actual filled-out example along with correspondence between the FDA and Novartis. In 2019 Novartis was applying for BTD for Capmatinib for metastatic NSCLC. Novartis went through some of the same steps Theralase is going through right now, It was a long process for them as well:

Novartis submitted 3 Preliminary Breakthrough Therapy Designation (BTD) requests before finally submitting their actual request for BTD for capmatinib for metastatic NSCLC which was granted.

The time between the first Preliminary BTD request and the actual BTD request was 8 months.

Here is the timeline:

On June 20, 2018, Novartis submitted a Preliminary Breakthrough Therapy Designation Advice request for capmatinib for the treatment of patients with MET Exon 14 skipping mutated advanced or metastatic NSCLC in both the 2nd/3rd line and treatment-naive setting. A teleconference was held between FDA and Novartis on July 5, 2018, in which FDA advised that submission of a BTDR is premature given inadequate follow up to adequately assess the durability of response/

Novartis submitted an updated Preliminary Breakthrough Therapy Designation (BTD) request on August 30, 2018, in follow-up to their previous Preliminary BTD tcon held on July 5, 2018. In the July 5, 2018 teleconference, FDA stated that a BTDR would be premature and recommended that Novartis re-submit a Preliminary BTD Request Advice meeting based on the results of in patients receiving first-line treatment for metasatic NSCLC (Cohort 5b) supported by the results in patients receiving second-line treatment (Cohort 4), given the apparent higher response rate in 5b as compared with 4. FDA further adviced that the request for preliminary BTD advice should be submitted when there is at least 6 months of follow up from the onset of response for all responders in Cohort 5b.

On September 20, 2018, a Type C teleconference was held to discuss the overall clinical development strategy to support a potential NDA submission based on results from Study CINC280A2201. FDA stated that:

An application seeking accelerated approval would be expected to contain at least 12 months of follow up from the onset of response for all responders in order to allow adequate assessment of the durability of responses.

the proposed clinical package, comprising 69 patients with previously treated cMET mutation-positive NSCLC enrolled in Cohort 4 and 24 treatment-nave patients with cMET mutation-positive NSCLC enrolled in Sub-cohort 5b, may be adequate to support filing of an NDA requesting accelerated approval if the observed ORR is large in magnitude and responses are durable.

the proposed NDA would need to include a description of the natural history of patients with cMET mutated NSCLC tumors (e.g., response to available therapy, prognosis).

On January 4, 2019, Novartis submitted a Preliminary Breakthrough Therapy Designation (BTD) advice request. FDA advised Novartis to submit a formal request for BTD.

On February 22, 2019, Novartis submitted a request for BTD for capmatinib; the BTD was granted for the treatment of patients with metastatic NSCLC with an MET exon 14 skipping mutation who have disease progression on or after platinum-based chemotherapy as stated in the letter issued on April 18, 2019.

APPLICATION NUMBER: 213591Orig1s000