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In a final draft guidance, the committee recommended the treatment for HR-positive HER2-negative early breast cancer patients, regardless of lymph node involvement.
The company will pause several gene therapy development programs, for which it intends to seek partners and other strategic alternatives.
A study published by Caris showed that certain tumor types had very low or no HER2 overexpression, which has implications for biomarker testing strategies.
The revenue for the cell therapy Carvykti and the EGFR-targeted lung cancer duo Rybrevant-Lazcluze contributed to double digit gains in oncology drug sales.