Roche obtains distinction in the United States for an anticancer drug

Roche obtains distinction in the United States for an anticancer drug
Roche obtains distinction in the United States for an anticancer drug

Zurich (awp) – Pharmaceutical giant Roche has obtained breakthrough therapy status from the United States Drug Authority (FDA) for its inavolisib. This experimental drug is intended for the treatment of a certain form of breast cancer, the Basel laboratory specified on Tuesday. This distinction opens the way to easier development and approval of the treatment.

In 70 to 80% of cases, breast cancer is hormone receptor positive (HR positive), meaning that diseased cells have receptors that attach to one or both of the hormones progesterone and estrogen, which can help make the tumor grow. However, 40% of patients with hormone-dependent breast cancer have a mutation in the PIK3CA gene, which exposes them to a poorer prognosis and more frequent resistance to treatment. This gene is most frequently mutated in the HR positive/HER2 negative cancer subtype.

Inavolisib is currently being studied in phase III in patients with HER2-negative hormone-dependent breast cancer with a PIK3CA mutation, at an advanced or metastatic stage. The treatment made it possible to double the survival rate without progression of the disease compared to the use of the sole combination of palbociclib and fulvestrant in first line therapy, underlines Roche in a press release.

The phase III study is evaluating inavolisib in combination with palbociclib (Ibrance) and fulvestrant.

Roche recalls that the therapeutic breakthrough status obtained from the FDA for inavolisib is the 29th for its oncology portfolio. Awarded to accelerate the development and approval process, this status is reserved for product candidates whose potential therapeutic benefit is very significant compared to existing treatments.

“The promising treatment based on inavolisib could transform the class of PI3K inhibitors, and could potentially become the standard and first-line treatment for these patients,” said Levi Garraway, medical director of Roche, quoted in the publication . The results of the study were sent to other health authorities, including the European Medicines Agency (EMA), specifies the laboratory.

Around 9:45 a.m., the Roche dividend voucher dropped 0.4% to 236.20 Swiss francs, in an SMI down 0.05%.

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