The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Pfizer Inc.’s (PFE) tyrosine kinase inhibitor (TKI) therapy, LORVIQUA, (lorlatinib, available in the U.S. under the brand name LORBRENA) for marketing authorization.
Notably, the European Commission (EC) will now verify the CHMP’s opinion, and the company expects the decision to come up in the next few months.
LORVIQUA, a tyrosine kinase inhibitor (TKI) therapy, is designed as a first-line treatment for adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).
Supporting Data
The regulator’s approval followed the results from the pivotal Phase 3 CROWN trial, which demonstrated that LORVIQUA reduced the risk of disease progression or death by 72% compared to XALKORI (crizotinib). The trial involved 296 participants with previously untreated advanced ALK-positive NSCLC.
Approvals
Earlier this year, LORVIQUA was approved by the U.S. Food and Drug Administration (FDA), under the brand name LORBRENA to treat adults with metastatic NSCLC whose tumors are ALK-positive, detected by an FDA-approved test. Previously, in 2019, LORVIQUA bagged the EC’s conditional marketing authorization as a monotherapy to treat adult patients with ALK-positive advanced NSCLC.
Official Comments
Chief Development Officer, Oncology, Pfizer Global Product Development, Chris Boshoff, said, “Over the past few decades, we’ve learned that ALK-positive advanced non-small cell lung cancer is a complex disease that is particularly challenging for the close to 40 percent of people with brain metastases at diagnosis. This positive CHMP opinion solidifies LORVIQUA as an effective first-line treatment option for those living with ALK-positive advanced non-small cell lung cancer in Europe.”
Analysts Recommendation
On December 17, Goldman Sachs analyst Chris Shibutani initiated coverage of Pfizer with a Hold rating and a price target of $51 (14.26% downside potential).
According to Shibutani, one-third of Pfizer’s current valuation is driven by the COVID-19 vaccine and therapeutic, while the company’s “extraordinary” efforts and investments have “resulted in the delivery of invaluable tools for addressing the COVID-19 pandemic”.
The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 7 Buys and 11 Holds. The average Pfizer price target of $55.18 implies 7.23% downside potential to current levels. Shares have gained 59.1% over the past year.
Risk Analysis
According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 25%, 25%, and 17%, respectively to the total 24 risks identified for the stock.
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