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Pfizer claims rapid FDA nod for Lorbrena

Green light is latest in a string of cancer drug approvals

The FDA has granted approval to Pfizer's next generation ALK inhibitor lung cancer treatment Lorbrena, which will help it defend its presence in the market.

Lorbrena (lorlatinib) is approved as a second or third line treatment for patients with ALK-positive metastatic non-small cell lung cancer (NSCLC), and is a follow up to Pfizer’s Xalkori, the first ALK inhibitor drug, launched in 2011.

Xalkori has, however, seen sales dwindle due to competition from newer drugs such as Novartis’ Zykadia and Takeda’s Alunbrig.

Lorbrena can also be used in patients who have seen disease progression on Roche’s Alecensa and Novartis’ Zykadia.

Follow-up ALK inhibitors are important in this treatment pathway, as many experience tumour progression after initial ALK inhibitor treatment, and need a second or third line option.

“Over the years, Pfizer has transformed research, management and treatment for patients with ALK-positive non-small cell lung cancer. Building upon our extensive understanding of tumour complexity and treatment resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumour mutations that may drive resistance to other ALK tyrosine kinase inhibitors,” said Andy Schmeltz, global president, Pfizer Oncology.

“We believe that Lorbrena will benefit patients with ALK-positive metastatic non-small cell lung cancer that have progressed on prior therapy and continue to deliver on our commitment to addressing unmet needs of cancer patients.”

The US regulatory body awarded the drug with an accelerated approval, acknowledging successful overall response rates of 48%.

However the approval is a conditional one, meaning that the FDA will continue to monitor results from further trials.

Mace Rothenberg, chief development officer, oncology, Pfizer global product development, said: “Lorbrena’s approval is an important milestone for patients, having demonstrated marked activity in a study that included a broad range of individuals with ALK-positive non-small cell lung cancer. This includes patients who were heavily pre-treated and facing limited options after receiving first- and second-generation ALK tyrosine kinase inhibitors.”

It’s the third approval in three months for Pfizer’s oncology unit after having seen success with PARP inhibitor Talzenna and Vizimpro, a drug that treats NSCLC patients who carries two specific EGFR mutations.

Article by
Gemma Jones

6th November 2018

From: Sales, Regulatory

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