The demand for checkpoint inhibitors, especially those targeting PD-1 and PD-L1, has risen significantly in the past couple of years. Cancer therapies that target either PD-1 or PD-L1 can stop them from attaching and prevent cancer cells from hiding.
PD-L1 inhibitors available on the market are Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio.
Keytruda continues to be a key contributor to Merck’s sales. In a short span of time, Keytruda has become Merck’s biggest product. It is now already approved for use in 20 indications across 12 different tumor types in the United States. The drug generated sales of almost $5.0 billion in the first half of 2019, reflecting a massive 56.6% surge year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. Keytruda sales are gaining from strong momentum in first-line lung cancer indication and recent launch in newer indications – renal cell carcinoma and adjuvant melanoma.
The Keytruda development program is also progressing well with Merck spending billions for research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in more than 1000 studies, including more than 600 combination studies. Merck is collaborating with several companies including Amgen, Incyte, Glaxo and Pfizer separately for the evaluation of Keytruda in combination with other regimens.
This year so far, Keytruda has gained several label expansion approvals. In July, Keytruda was approved by the FDA as a monotherapy for advanced esophageal cancer. In June, it was approved by the FDA for first-line treatment of recurrent or metastatic HNSCC and for previously treated advanced small-cell lung cancer. In April, the FDA gave approval to Keytruda in combination with Pfizer’s Inlyta for the first-line treatment of advanced renal cell carcinoma as well as for an expanded first-line lung cancer patient population. In the first quarter, it was approved by the FDA as an adjuvant therapy for high-risk stage III melanoma and for five new cancer line extensions in Japan. All these label expansion approvals should drive sales of Keytruda higher in the future quarters.
Several regulatory decisions for new indications in the United States as well as in Europe are pending in the rest of the year, which if approved can further boost sales.
Though Keytruda has its share of side effects and has suffered some major pipeline setbacks, we believe the drug has strong growth prospects based on increased utilization, recent approvals for new indications and potential additional approvals worldwide.
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