USA – Draft AML guidance takes targeted therapies into account

The US Food and Drug Administration(FDA)  has issued a new draft guidance for developers of drugs and biologics to treat acute myeloid leukemia (AML).

The new draft guidance takes into account a shift in the treatment landscape for AML as new targeted treatments are being developed for this and other cancers. « In some cases, these newer approaches may extend survival without the prospect for cure, but extending survival may be a meaningful benefit for patients who would live for only weeks if left untreated, » says the guidance.

The draft guidance, said the agency, represents an updated approach to clinical trial design and regulatory submissions.  Among the shifts in AML therapy that the guidance considers are an expansion of the reason for treatment, a broader patient population and the emergence of new drug classes that are alternatives to traditional, highly cytotoxic drugs…