FDA approves Zykadia for late-stage lung cancer
pharmafile | April 30, 2014 | News story | Research and Development, Sales and Marketing | Cancer, FDA, Novartis, lung, zykadia
Novartis’ ‘breakthrough’ drug Zykadia has been approved by the FDA to treat lung cancer patients with a particular genetic mutation.
The US regulator allowed Zykadia (ceritinib) to be approved under an accelerated programme, which has seen the drug hit the market four months quicker than originally expected.
Zykadia now has a US licence for patients with late-stage (metastatic) non-small cell lung cancer (NSCLC) who over-express a certain genetic mutation, known as anaplastic lymphoma kinase (ALK).
Specifically, it works as an ALK tyrosine kinase inhibitor that blocks certain proteins which promote the development of cancerous cells. Its focus will be on a small sub-population as only round 1-7% of patients express the ALK gene, and this mutation is normally associated with non-smokers.
It is also intended as a second-line treatment and can only be used for patients who have failed on Pfizer’s lung cancer treatment Xalkori (crizotinib), the only other approved ALK tyrosine kinase inhibitor.
Pfizer’s drug has proven effective as a first-line treatment, but some patients become resistant to the treatment – a common problem for many oncology products.
Novartis’ new drug will fill the role of helping those patients who are no longer benefiting from Xalkori, and will most likely be seeking a first-line approval in the future, given the greater revenue potential.
Xalkori saw sales of $350 million last year, but analysts at Cowen and Co have predicted the medicine could generate annual peak sales of around $1 billion by 2020, putting it into the blockbuster bracket.
Analysts’ predictions on Novartis’ new medicine put the drug making around $350 million in peak annual sales, but will struggle to gain as much traction as Xalkori, given its current treatment setting.
“Zykadia represents an important treatment option for ALK+ NSCLC patients who relapse after starting initial therapy with crizotinib,” says lead investigator Alice Shaw of the Massachusetts General Hospital Cancer Center, Boston.
“This approval will affect the way we manage and monitor patients with this type of lung cancer, as we will now be able to offer them the opportunity for continued treatment response with a new ALK inhibitor.”
The drug has also been sent to the European Medicines Agency, and Novartis is now awaiting a decision from the EU regulator.
Speedy review
The FDA is approving Zykadia under the agency’s accelerated approval programme, which allows authorisation of a drug to treat a serious or life-threatening disease, based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
This programme provides earlier patient access to promising new drugs while the company conducts additional clinical trials to prove its longer term efficacy.
“The approval of Zykadia less than three and a half years after the first patient entered our clinical trial exemplifies what is possible with a highly focussed approach to drug development and strong collaboration,” says Alessandro Riva, president of Novartis Oncology.
“The dedication of clinical investigators, patients, the FDA and others has enabled us to bring this medicine to patients in need as swiftly as possible.”
Zykadia is the fourth drug with breakthrough therapy designation to receive FDA approval. Its most recent data were gleaned from a clinical trial of 163 participants with metastatic ALK-positive NSCLC.
All participants were treated with the drug and results showed that about half of the participants had their tumours shrink, and that this effect lasted an average of about seven months.
Lung cancer is the leading cause of cancer-related deaths among men and women. According to the National Cancer Institute, an estimated 224,210 Americans will be diagnosed with lung cancer, and 159,260 will die from the disease this year.
About 85% of lung cancers are NSCLC, making it the most common type of lung cancer.
Ben Adams
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