14th Apr 2020 09:23
(Alliance News) - AstraZeneca PLC and Merck & Co Inc on Tuesday said the US Food & Drug Administration has approved Koselugo, or selumetinib, for the treatment of neurofibromatosis type 1 in patients two years of age and older.
Neurofibromatosis type 1 is a genetic condition that causes tumours to grow along nerves.
Pharmaceutical partners AstraZeneca and Merck said the approval by the regulatory authority was based on positive results from Sprint Phase II Stratum 1 trial. When treated with selumetinib as a twice-daily oral monotherapy, 66% of paediatric patients with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas saw at least a 20% reduction in tumour volume.
The drug is now the first medicine indicated for the treatment of paediatric patients with neurofibromatosis type 1 plexiform neurofibromas, AstraZeneca said.
"Previously there were no medicines approved for this disease. This approval has the potential to change how symptomatic, inoperable NF1 plexiform neurofibromas are treated and provides new hope for these patients," said Roy Baynes, chief medical officer of Merck's Research Laboratories.
Separately, AstraZeneca said its Adaura Phase III trial for Tagrisso, or osimertinib, for the treatment of lung cancer showed positive results.
For three years, the trial assessed Tagrisso as a first-line treatment for "patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer". The trial will now continue to assess its secondary endpoint of overall survival.
"We are thrilled by the recommendation to unblind the Phase III Adaura trial much earlier than expected and are incredibly excited with these unprecedented results in patients with early-stage EGFR-mutated non-small cell lung cancer. Lung cancer is a devastating diagnosis and for the first time an EGFR-targeted medicine can now provide the hope of cure," said Jose Baselga, executive vice president, Oncology R&D.
AstraZeneca shares in London were up 5.7% at 7,525.21 pence each on Thursday morning. Merck shares ended 2.3% lower on Monday at USD80.54 in New York, with down 0.3% at USD80.33 in Tuesday's pre-market trading.
By Ife Taiwo; [email protected]
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