UK pharmaceutical giant AstraZeneca (AZN) announced two EU approvals for cancer drug Lynparza and strong efficacy data for lung cancer drug Tagrisso on Monday, but with the general market down over 3%, investors were in no mood to cheer the news with the shares falling 1% to £86.6.
LYNPARZA
Cancer drug Lynparza forms part of a strategic oncology collaboration between AstraZenca and US pharmaceutical firm Merck & Co, who are seeking to co-develop and commercialise the drug.
The European Medicines Agency (EMA) has recommended the drug for marketing authorisation across the EU for patients with prostate cancer.
AstraZeneca executive vice president of oncology, Jose Baselga, said, ‘This recommendation for Lynparza brings us closer to making the only PARP inhibitor to improve overall survival in this setting available to men in the EU.
‘BRCA testing should now become a critical step in the diagnosis and determination of treatment for men with advanced prostate cancer in the EU.’
Regulatory reviews are continuing in other parts of the world while US approval was given in May 2020.
The drug was also given the green light by the EMA as the 1st-line maintenance treatment for patients with advanced ovarian cancer, based on data from a phase three trial which was reported in the New England Journal of Medicine.
The addition of Lynparza in combination with bevacizumab improved progression free survival to 37 months compared with 17.7 months for bevacizumab alone.
TAGRISSO
AstraZeneca also announced results from the ADURA phase three trials which showed its lung cancer drug Tagrisso reduced the risk of disease recurrence or death by 83% compared with the placebo.
The placebo group do not know they aren’t getting a fake drug and are used as a control to prevent statistical bias on interpreting the results.
The estimated probability of observing disease recurrence in the brain at 18 months for patients treated with Tagrisso was less than 1% versus 9% for placebo among patients who had not experienced another type of recurrence.
Masahiro Tsuboi, a principal investigator in the ADAURA Phase III trial, said, ‘These new data showing low rates of recurrence, particularly in the brain, combined with the remarkable disease-free survival benefit, clearly demonstrate that Tagrisso provides patients with more time living cancer-free.’
