Pfizer's shares saw a 1.6% increase on Monday following the recent approval by the U.S. Food and Drug Administration (FDA) of the expanded use of Padcev, an antibody-drug conjugate (ADC) obtained through Pfizer's acquisition of Seagen. The FDA's approval allows Padcev to be used in combination with Merck's Keytruda for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This approval marks a groundbreaking milestone as the first ever combination of an ADC product and a PD-L1 inhibitor to be approved for the treatment of advanced bladder cancer.

Antibody-drug conjugates have been recognized as a disruptive innovation within the pharmaceutical industry, as they have the potential to revolutionize cancer treatment by utilizing antibodies to target tumors and deliver cytotoxic molecule drugs. This advancement presents a promising alternative to the use of platinum-containing chemotherapy, which has been the standard of care for first-line la/mUC treatment for many years.

The FDA's approval of Padcev in combination with Keytruda is based on data collected from the phase III EV-302 (KEYNOTE-A39) study. Results from this study revealed that the combination therapy nearly doubled the median overall survival (OS) and median progression-free survival (PFS) rates in the advanced bladder cancer patient group when compared to platinum-containing chemotherapy. Additionally, patients treated with the combination experienced a significant 53% reduction in the risk of death as well as a 55% reduction in the risk of cancer progression or death. Pfizer believes that these impressive outcomes demonstrate the potential of Padcev in combination with Keytruda for the first-line treatment of patients with la/mUC.

Currently, Padcev in combination with Keytruda is approved on an accelerated basis for the treatment of la/mUC in adult patients who are ineligible for cisplatin-containing chemotherapy. The EV-302 study served as the confirmatory study required to convert this accelerated approval to full approval. With the recent FDA approval, Padcev in combination with Keytruda is now eligible for expanded use in patients with la/mUC who are eligible to receive cisplatin chemotherapy.

The acquisition of Seagen by Pfizer, which closed on December 14, further solidifies Pfizer's portfolio of cancer drugs by incorporating a class of ADCs. Seagen is a renowned pioneer in ADC technology and currently markets four cancer drugs: Adcetris, Padcev, Tukysa, and Tivdak. Pfizer anticipates that this acquisition will significantly augment its early-stage oncology pipeline, with projected revenues of $3.1 billion from Seagen in 2024.

It is important to note that Pfizer currently holds a Zacks Rank #3 (Hold). However, investors may want to consider other drug/biotech companies such as Novo Nordisk and Puma Biotech, both of which currently hold a Zacks Rank #1 (Strong Buy).

In conclusion, the FDA's approval of the expanded use of Padcev, in combination with Keytruda, for the treatment of advanced bladder cancer has elicited a positive response from Pfizer, leading to a rise in the company's shares. This approval not only signifies a significant stride in the treatment of advanced bladder cancer but also reinforces Pfizer's commitment to advancing cancer therapies and expanding its oncology pipeline.