AZ sees triple approval in Japan for cancer and COPD drugs

AstraZeneca has seen three of its drugs approved by the Japanese regulator – a new indication for its cancer drug Lynparza, and two new combination therapies for patients with chronic obstructive pulmonary disease (COPD).

AZ is developing cancer drug Lynparza (olaparib) in partnership with US-based Merck & Co and announced that the drug has been approved in its new indication as maintenance therapy after first line chemotherapy in patients with BRCA-mutated advanced ovarian cancer.

Approval from the Japanese Ministry of Health, Labour and Welfare was based on data from the phase 3 SOLO-1 trial testing Lynparza as maintenance monotherapy compared with placebo in patients with the disease.

Results for SOLO-1 were announced in October last year at the European Society for Medical Oncology (ESMO).

They showed that at 40.7 months of follow-up, the median time of progression for patients treated with Lynparza had not been reached, compared with 13.8 months for those on placebo.

The approval follows hot on the heels of European approval in the new indication, based on the same data set.

It is the third indication for Lynparza, a poly (ADP-ribose) polymerase (PARP) inhibitor, with others planned including a combination with Roche’s Avastin (bevacizumab) as a first line treatment for endometrioid, fallopian tube or peritoneal ovarian cancer regardless of BRCA status.

Lynparza was the first PARP drug to hit the market, approved in ovarian cancer in 2014, but since then it has encountered competition from rivals such as Clovis Oncology with Rubraca (rucaparib).

Tesaro has developed and marketed another PARP drug Zejula (niraparib), and the US biotech has been snapped up by GlaxoSmithKline as part of a new focus on oncology, although these drugs are not yet available in Japan.

The Japanese regulator also approved AZ’s Breztri Aerosphere (budesonide+glycopyrronium+formoterol) for patients with chronic COPD, a triple combination therapy to relieve symptoms.

It is the first approval for the triple combination drug globally, available in a pressurised metered-dose inhaler, and is based on results from the phase 3 KRONOS trial.

AZ’s Bevespi Aerosphere  (glycopyrronium+formoterol) has also been approved in Japan as a long acting fixed-dose dual bronchodilator for COPD. It is the first approval in Japan for the new combination.