Based on the data, senior vice president of Global Development and Medical Affairs at Bristol-Myers Squibb Brian Daniels noted that the drugmaker “plan to initiate registrational studies for anti-PD-1 in non-small-cell lung cancer and renal cell carcinoma this year and late 2012, early 2013 for metastatic melanoma.” Leerink Swann analysts suggested that PD-1 inhibitors such as BMS-936558, which Bristol-Myers Squibb is developing with Ono Pharmaceutical, “could be the most exciting clinical and commercial opportunity in oncology,” partly because such drugs might be able to treat a variety of cancers. Other companies developing compounds that work by similar mechanisms include GlaxoSmithKline, Merck & Co., Roche and Teva.
I heard this yesterday. Registrational studies means the results count for the final application to the FDA (usually means a phase III, double blind test- expensive). However, I was told that properly designed phase II studies can also sometimes be included as registration studies, but not sure how that would work. No question, this is a slow process.
A “registrational study” simply refers to a clinical trial registered with a national drug approval body such as CDER at the FDA. The trials mentioned have been listed or registered for some time. The last time that I looked, they were not recruiting. The melanoma trial, however, is not listed yet although, surpisingly, one for Hematologic cancers is.
My issue with BMS isn’t that they are doing nothing for melanoma patients, its that they aren’t doing enough and are doing it too slowly.
Here is what I heard from BMS: A registrational development program refers to late development clinical trials that are included in a filing that is submitted to the FDA for approval. In the case of anti-PD-1, we are moving from early clinical development in Phase 1 trials straight to a Phase 3 registrational program for three tumor types – lung, melanoma and kidney cancer. We expect the registrational trials for melanoma to begin at the end of this year, early next year.
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