The Latest FDA Approvals and Updates Patients with Cancer May Have Missed

The Latest FDA Approvals and Updates Patients with Cancer May Have Missed

September 9, 2020

There have been several drug approvals and updates from the Food and Drug Administration (FDA) in the cancer space over the last several weeks.

Here, CURE® looks back at some of the latest approvals and updates from the FDA.

  • The FDA granted a priority review designation to melflufen in combination with dexamethasone for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who had previously received multiple lines of therapy, according to the agent’s manufacturer, Oncopeptides.
  • The FDA approved the oral therapy Onureg (azacitidine 300 milligram (mg) tablets, CC-486) for the continued treatment of adults with acute myeloid leukemia (AML) who have achieved an initial complete remission following intensive induction chemotherapy and are not able to complete intensive curative therapy, according to Bristol Myers Squibb.
  • FoundationOne Liquid CDx, a comprehensive multi-tumor liquid biopsy test, was approved for all solid tumors with multiple companion diagnostic indications, according to the biopsy test’s developer, Foundation Medicine.
  • A generic version of Pemetrexed has been approved for use by itself in patients with locally advanced or metastatic non-squamous non-small cell lung cancer that has not progressed following four cycles of initial treatment with platinum-based chemotherapy.
  • The expansion of Kyprolis (carfilzomib) in combination with Darzalex (daratumumab) plus dexamethasone was approved in once- and twice-weekly dosing regimens for the treatment of patients with relapsed or refractory multiple myeloma who have received a maximum of three prior lines of therapy, according to the agent’s manufacturer, Amgen.

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