The success of drug developers hinges on regulatory approvals for their medications. Considering that, it was hardly surprising that Pfizer (PFE 0.55%) stock had a good Monday on the market. Following its latest Food and Drug Administration (FDA) nod, the company's shares closed the day 1.6% higher, topping the S&P 500 index's 0.5% rise.
Cancer drug Padcev approved
That morning, Pfizer divulged that the FDA approved Padcev, the cancer drug developed with Japan's Astellas Pharma, to treat bladder cancer. Padcev has won the nod as part of a first-line combination therapy with Keytruda, Merck's blockbuster cancer drug.
The FDA's approval is based on the results of a phase 3 clinical trial of the two drugs used in combination. These demonstrated that taken together, the pair lowered the risk of death by 53% in patients with previously untreated bladder cancer, when compared to traditional chemotherapy.
This is not Padcev's first approval. It won its inaugural FDA nod for treating bladder cancer at the end of 2019, however that was limited to patients with certain types of cases.
News of the latest approval comes mere days after Pfizer announced the completion of its acquisition of Seagen, Padcev's developer. In May, Pfizer offered to pay a total of $43 billion in cash for the biotech.
Still in the laboratory
This isn't the end of the story for Padcev. It is currently being evaluated for use as a solo agent, and in combination with Keytruda for other forms of bladder cancer. Additionally, it is being studied to combat head and neck squamous cell carcinoma.
