The FDA, on Friday, warned of rare but severe lung inflammation associated with the use of some advanced breast cancer medicines, Pfizer’s (PFE - Free Report) Ibrance, Eli Lilly’s (LLY - Free Report) Verzenio and Novartis’ (NVS - Free Report) Kisqali. The FDA said that the related lung issues can prove to be fatal for the patients.
The FDA approved new warnings about the inflammation risk to be added to the labels of these cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor medicines. The FDA also approved a patient package insert for the entire class of these medicines, which work by inhibiting cyclin-dependent kinases 4 and 6, which interferes with the division of cancer cells and helps stop tumor growth.
While shares of Pfizer declined 1%, that of Lilly and Novartis went down by 0.5% and 2.8%, respectively, on Friday.
The FDA reviewed data from completed and ongoing clinical studies on CDK 4/6 inhibitors that mentioned some serious cases of patients experiencing lung inflammation issues like interstitial lung disease (ILD) and pneumonitis, including fatal cases.
The FDA has asked patients using these drugs to watch for symptoms like difficulty in breathing, shortness of breath even while at rest and other worsening symptoms involving their lungs. It also instructed doctors to regularly monitor patients for symptoms indicative of ILD/pneumonitis. In patients, who have developed ILD/pneumonitis, the FDA instructed permanent discontinuation of CDK 4/6 inhibitor medicines.
Nonetheless, the FDA’s safety alert emphasized that the overall benefit of these CDK 4/6 inhibitor medicines are greater than the risks. However, we believe that these additional warnings may affect sales of the three drugs, to an extent, in future quarters.
While Ibrance was approved by the FDA in 2015, the other two medicines were given the green signal much later in 2017. Ibrance generated sales of $2.39 billion in the first half of 2019 while Verzenio and Kisqali, garnered sales of $243.3 million and $202 million, respectively in the same time frame. All three medicines are approved for use in combination with an aromatase inhibitor to treat adults with HR+, HER2- breast cancer that is metastatic, or in other words, has spread to other parts of the body.
Though several drugs with different mechanism of action are approved to treat breast cancers, a relatively newer class of drugs approved to treat the disease is PARP inhibitors like Merck (MRK - Free Report) and AstraZeneca’s (AZN - Free Report) Lynparza.
While Lilly and Novartis have a Zacks Rank #2 (Buy), Pfizer has a Zacks Rank #4 (Sell).
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