This article reviews the three novel drugs approved by the FDA in March 2022 in detail.
together with Dr. Naveed Yasin, Jesse Keicher, Dr. Jennifer Huen, and Dr. Adrian Parodi
- Ztalmy® (ganaxolone): An oral GABAA receptor positive allosteric modulator to treat seizures in cyclin-dependent kinase-like 5 deficiency disorder.
- PluvictoTM (lutetium Lu 177 vipivotide tetraxetan): A therapeutically active, injectable radioligand to treat prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer following other therapies
- OpdualagTM (relatlimab and nivolumab): Relatlimab is the novel component (a Lag-3 blocking antibody). The combination is approved to treat unresectable or metastatic melanoma
Some interesting snippets about each drug from our report:
- Unlike recently approved brexanolone, ganaxolone has a long half-life (34 h) and can be given orally. Since it does not form GABAA-inhibiting metabolites as brexanolone does, it can also be used to treat seizures.
- Most recognize the target of Pluctivo as PSMA (prostate-specific membrane antigen) a famous marker for prostate cancer. It’s also known as glutamate carboxypeptidase II, catalyzing the hydrolysis of N-acetylaspartylglutamate, hence the peptidic nature of the drug ligand.
- Relatlimab targets Lag-3, making Lag-3 the third immune checkpoint mechanism with an approved drug molecule (after CTLA-4 and PD-1/PD-L1). TIGIT was widely anticipated to be the next immune checkpoint to be approved until disappointing Ph. III SKYSCRAPER-02 results were recently disclosed by Roche.
The full Premium report below summarizes for each drug:
- Key endpoints
- Disease context
- Biological mechanism of action
- Pharmaceutical properties
- Prior treatment options
- Commercial, regulatory, and industry context
See our overview of all 36 of the novel small molecule and large molecule FDA approvals for 2022 here.
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