Roche's Pertuzumab (Perjeta®) Nears Third Indication Approval in China for HER2-Positive Metastatic Breast Cancer

On November 22, the application status for the new indication of Perjeta® (generic name: pertuzumab), an innovative targeted therapy for breast cancer under Roche, was updated to “under review” (acceptance number: JXSS1800042). This will be the third indication approved for Perjeta in the Chinese market since its initial approval last year.

Previously, Roche publicly disclosed that the large-scale Phase III CLEOPATRA trial demonstrated that pertuzumab plus trastuzumab as first-line treatment for HER2-positive advanced breast cancer increased overall survival (OS) to 56.5 months, fully confirming dual-targeted therapy as the standard of care for the comprehensive management of HER2-positive breast cancer.

Pertuzumab (Perjeta) is the second breast cancer targeted therapy launched by Roche in China, following trastuzumab (Herceptin). In 2018, trastuzumab generated $7.1 billion in sales, while pertuzumab achieved $2.359 billion, with both ranking among the top five breast cancer drugs globally by sales revenue.

On December 19, 2018, the first indication for Perjeta® was approved in China for adjuvant treatment in combination with trastuzumab and chemotherapy in patients with HER2-positive early breast cancer at high risk of recurrence, significantly reducing the risk of recurrence in this patient population. This also marked the official entry of anti-HER2 therapy in China into the era of dual-targeted treatment.

On August 20, 2019, the second indication for pertuzumab was approved in China. In combination with trastuzumab and chemotherapy, it is used for the neoadjuvant treatment of patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (tumor diameter >2 cm or node-positive), as part of the overall treatment regimen for early breast cancer.

The new indication, which is about to be approved, was submitted for marketing application on January 5, 2019 and accepted by the CDE. On February 25, it was included in the priority review process due to its significant therapeutic advantage as an innovative drug, with a total review period of 319 days.