It’s been called outrageous, tragic, inhumane, unconscionable. I’m talking about the FDA’s reversal and refusal to approve a life saving drug for stage 4 metastatic melanoma. The final ruling denying Replimune’s RP-1 came down April 10th and it may mark the end of the road for the drug; the end of hope for patients who were counting on it for survival.
If you follow the Claire Marie Foundation, you will know that in the last eight months we have stepped out of our normal role of melanoma prevention and education to join more heavily in the advocacy fight on behalf of stage 4 melanoma patients. In the most basic of terms, we joined forces with international oncologists, researchers, patients and melanoma advocacy groups to fight for approval of the holy grail of drug therapies for those most desperate; stage 4 metastatic melanoma patients. RP-1, when teamed with Opdiva, showed an incredible response with few side effects in 34% of the patients including full remission for many patients. Clinical trials checked every box and standard. But under the FDA of the Trump Administration, existing scientific standards were tossed aside in the favor of individual opinion. Posturing replaced compassion. Thus, access to RP-1 has come to an end. Pharmaceutical development is not cheap nor free.
The impact is real, the ripple effect unimaginable. In the eight months battling the FDA for approval of RP-1, approximately 5,744 people died of stage 4 melanoma in the United States. I can only pray that doesn’t include someone you love.
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