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Pfizer's (PFE) Lorbrena Gets FDA Nod for First-Line Lung Cancer

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Pfizer Inc. (PFE - Free Report) announced that the FDA has approved its supplemental new drug application (sNDA) for its tyrosine kinase inhibitor cancer drug, Lorbrena (lorlatinib), earlier than expected. The sNDA is seeking label expansion of Lorbrena as a first-line treatment for ALK-positive metastatic non-small cell lung cancer (NSCLC).

The sNDA was supported by data from the phase III CROWN study, evaluating the drug in previously untreated advanced ALK-positive NSCLC patients.

Please note that Lorbrena was already approved for treating ALK-positive metastatic NSCLC in previously-treated patients whose disease has progressed following treatment with Pfizer’s another NSCLC drug, Xalkori (crizotinib) or Roche’s (RHHBY - Free Report) Alecensa (alectinib) or Novartis’ (NVS - Free Report) Zykadia (ceritinib). Based on the data from the CROWN study, the FDA granted full approval for the drug in this treatment setting.

Pfizer’s stock is down 5.6% in the past year against 4.3% increase for the industry.

The CROWN study compared efficacy of Lorbrena in treatment-naïve advanced ALK-positive NSCLC patients to Xalkori. Data showed that treatment with Lorbrena reduced risk of progression or death by 72% compared to Xalkori. Data from the study also showed that Lorbrena can significantly improve outcomes in previously untreated ALK-positive NSCLC patients with brain metastases.

Sales of Lorbrena improved approximately 11% year over year in 2020 to $204 million. Approval as first-line treatment is likely to accelerate its sales growth. Moreover, Lorbrena is a better alternative for ALK-positive NSCLC patients from Pfizer’s portfolio that is patent protected till 2033 in the United States.

We note that the sNDA for Lorbrena was reviewed by the FDA under Project ORBIS, which provides a framework for potential concurrent submissions and collaborative review with health authorities in Canada, Singapore, Switzerland, Australia, Brazil and the United Kingdom. This may lead to approval for the drug in the aforementioned countries soon. Moreover, a similar label expansion application for Lorbrena is under review in Europe.

Meanwhile, Pfizer and its partner BioNTech (BNTX - Free Report) are progressing well with the supply of their coronavirus vaccine, BNT162b, in more than 50 countries where an approval for emergency/temporary/conditional use has been granted. Pfizer expects the vaccine to generate approximately $15 billion in sales this year.

Zacks Rank

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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