Brand New Drugs (aka Novel Medicines) & What You Should Know

Overprescribed

We're talking about several things that people should know about new FDA-approved medicines (also called novel medicines) that hit the market for the first time. We're also taking a quick look at 3 recent examples: two new skin cancer drugs for melanoma and 1 new drug that was recently approved to treat smallpox.

Show note links:

Drugs mentioned in this episode (click links to access the Drug Trial Snapshots for each drug directly from the FDA's website)...

BRAFTOVI (encorafenib)

MEKTOVI (binimetinib)

TPOXX (tecovirimat)

Check out skin cancer statistics on melanoma from the Skin Cancer Foundation and the American Academy of Dermatology.

MEKTOVI's FDA approval letter.

BRAFTOVI's FDA approval letter.

Check out this YouTube clip on what one of the BRAFTOVI/MEKTOVI clinical trial investigators has to say about these new drugs.

View the public-facing clinical trial summary on MEKTOVI and BRAFTOVI from the ClinicalTrials(dot)gov website.

Self.com article "Why Are Black People Less Likely To Get Melanoma But More Likely To Die From It?"

For more on SIGA Technologies (the company that manufacturers the smallpox drug), check this out on Wikipedia.

CBS news article on this recently FDA-approved smallpox product, TPOXX.

Do you want to dig deeper into the research surrounding this new smallpox drug? Check out this very detailed, SIGA-drafted FDA Advisory Committee Briefing Document from an advisory committee meeting re: TPOXX (tecovirimat) that was held on May 1, 2018.

Are you experiencing unwanted or undesired side effects? Report to the FDA. Call 1-800-332-1088 or visit www.fda.gov/medwatch