Roche closes on EU approval for Tecentriq in breast cancer

Roche is heading for EU approval of Tecentriq as first-line therapy for triple-negative breast cancer (TNBC), ahead of its checkpoint inhibitor rivals. The Committee for Medicinal Products for Human Use (CHMP) backed the use of the PD-L1 inhibitor in patients with locally-advanced or metastatic TNBC that cannot be treated with surgery and who haven’t previously received chemotherapy. The EMA typically approves drugs a few weeks after a positive CHMP opinion. The new indication – which was approved by the FDA in March – is seen as a big commercial opportunity for Tecentriq (atezolizumab) as it is the first checkpoint inhibitor to be cleared for use in any form of breast cancer. It not only represents a sizeable patient population, affecting around 15% of the 2 million women diagnosed with breast cancer each year worldwide, but also has no competition yet from other cancer immunotherapies such as Merck & Co/MSD’s market leading Keytruda and Bristol-Myers Squibb’s Opdivo. The CHMP positive opinion applies to women whose tumours express PD-L1 but lack receptors for oestrogen, progesterone or HER2 – effectively preventing treatment with hormonal therapies or anti-HER2 drugs like Roche’s Herceptin. TNBC is a particularly aggressive form of breast cancer with treatment options that until recently were mostly limited to surgery, radiotherapy and chemotherapy, depending on the stage of the disease. AstraZeneca’s Lynparza and Pfizer’s Lynparza can be used in TNBC, but only in patients whose cancers express the BRCA biomarker. Five-year survival rates tend to be much lower with TNBC than with other breast cancer types, so Tecentriq is a welcome new addition to the treatment options for this form of the disease.
Analysts have also suggested that Roche has a lead of at least a year over other checkpoint inhibitors in TNBC, with Keytruda considered to be closest behind with phase 3 results due later this year.