The US Food and Drug Administration has assigned a fast track designation to a new CAR-T cancer treatment for multiple myeloma patients.

The designation comes after two other CAR-T treatments received Food and Drug Administration (FDA) approval for use in patients earlier this year.

This latest designation will give Allogene Therapeutics’ allogeneic CAR-T treatment, ALLO-605, an accelerated development and review pathway.

FDA fast track designations are granted to drugs which could prevent or cure life-threatening illnesses where no treatment currently exists, or where new ones being developed represent a better solution.

Big year for CAR-T

ALLO-605’s fast track designation is the latest in a series of FDA decisions which are making it easier for CAR-T treatments to reach patients.,

In March, the FDA approved Abecma – also used to treat multiple myeloma – for use in patients that other treatments haven’t helped or who have suffered after the cancer returned.

Earlier, in February, Bristol Myers Squibb’s Breyanzi CAR-T drug was similarly approved for patients with certain types of blood cancers, known as B-Cell lymphomas.

Meanwhile China’s National Medical Products Administration (NMPA) recently permitted doctors to administer another CAR-T treatment, Yescarta.

This marks the first time a CAR-T treatment has received the seal of approval from Chinese authorities and is regarded as a milestone in the global adoption of the drugs.

Australia plays its part

As CAR-T treatments increasingly find their way to patients, Australian company Prescient Therapeutics is working to make them safer and give medical professionals more control over the treatments.

While traditional CAR-T therapies – created by genetically modifying a patient’s own immune cells to attack cancer – are effective, the current generation of drugs have a number of shortcomings.

For example, current generation CAR-T drugs can only attack one target at a time and medical practitioners will have no control over the level of cell activity once the drug is infused into a patient.

Prescient Therapeutics’ next generation OmniCAR platform however aims to enable doctors to tune CAR-T cell activity up or down to provide superior safety and control, as well as being able to redirect CAR-T cells to attack new targets.

Recent immunogenicity testing of the OmniCAR platform found its key binding components, known as SpyTag and SpyCatcher, are unlikely to cause unwanted immune responses in patients.

The company is currently working with the Peter MacCallum Cancer Centre to conduct further research on OmniCAR and progress its development.

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Sources:

• Allogene: Allogene Therapeutics Granted FDA Fast Track Designation for ALLO-605, the First TurboCAR™ T Cell Therapy, for the Treatment of Relapsed/Refractory Multiple Myeloma
• US Food and Drug Administration: FDA approves idecabtagene vicleucel for multiple myeloma
• US Food and Drug Administration: FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma
• Proactive investors: Prescient Therapeutics signs CAR-T agreement with Peter Mac Cancer Centre