User:MaryGaulke/sandbox/Avapritinib requests

Hi! I have a COI: Blueprint Medicines, the maker of avapritinib, is a client of my employer, Porter Novelli. Requesting some updates to this article:

Lead

 * Add after "used for the treatment of advanced systemic mastocytosis":
 * and indolent systemic mastocytosis
 * Reference provided in the additions for the article body below.


 * Add to end of first paragraph:
 * It is approved for use in the United States, the European Union, and China.

Medical uses

 * Update
 * Avapritinib is also indicated for the treatment of adults with advanced systemic mastocytosis, aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia (MCL).
 * to
 * Avapritinib is also indicated for the treatment of adults with advanced systemic mastocytosis, aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, mast cell leukemia (MCL), and indolent systemic mastocytosis.

History

 * Update
 * The U.S. Food and Drug Administration (FDA) approved avapritinib in January 2020.
 * to
 * In January 2020, the U.S. Food and Drug Administration (FDA) approved avapritinib for the treatment of GIST harboring a PDGFRA exon 18 mutation.


 * Update
 * Avapritinib showed a median PFS of 4.2 months compared to 5.6 months for regorafenib. The difference in median PFS between the avapritinib and regorafenib groups was not statistically significant. The overall response rate was 17 percent for the avapritinib group and 7 percent for the regorafenib group. The VOYAGER trial evaluated the efficacy and safety of avapritinib (N=240) versus regorafenib (N=236) in patients with third- or fourth-line GIST.
 * to
 * In the VOYAGER trial, Avapritinib showed a median PFS of 4.2 months compared to 5.6 months for regorafenib. The difference in median PFS between the avapritinib and regorafenib groups was not statistically significant. The overall response rate was 17 percent for the avapritinib group and 7 percent for the regorafenib group. The trial evaluated the efficacy and safety of avapritinib (N=240) versus regorafenib (N=236) in patients with third- or fourth-line GIST.
 * Clarifying that the whole paragraph is about the VOYAGER trial.


 * Update
 * Avapritinib was approved for medical use in the European Union in September 2020.
 * to
 * Avapritinib was approved for medical use for the treatment of GIST harboring a PDGFRA exon 18 mutation in the European Union in September 2020.


 * Add to the beginning of the final paragraph of the section:
 * The EXPLORER and PATHFINDER trials evaluated avapritinib in patients with advanced systemic mastocytosis. The overall response rate in both both trials combined was 57 percent, with 28 percent experiencing complete remissions and 28 percent partial remissions.
 * This has the same citation as the following sentence, so I didn't duplicate it above.


 * Add to end of section:
 * The European Commission approved avapritinib for advanced systemic mastocytosis after at least one prior therapy in March 2022.


 * The PIONEER trial found that patients with indolent systemic mastocytosis (ISM) experienced a statistically significant difference in the average change in total symptom score with avapritinib compared to a placebo. In May 2023, the FDA approved avapritinib for adults with ISM, and the European Commission granted approval for the same indication in December 2023.

Thanks for your time!