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When Did Keytruda Gain FDA Approval? A Look Back at the Journey of a Revolutionary Cancer Treatment

The FDA approval of Keytruda (pembrolizumab) in 2014 marked a significant milestone in the treatment of various types of cancer. But what led to this breakthrough, and what has been the impact of this revolutionary treatment on the medical community?

The Early Days of Immunotherapy

Immunotherapy, a type of cancer treatment that harnesses the power of the immune system to fight cancer, has been around for decades. However, it wasn't until the early 2000s that researchers began to understand the potential of checkpoint inhibitors, a class of immunotherapies that work by releasing the brakes on the immune system.

The Development of Keytruda

Merck & Co. began developing Keytruda in the early 2000s, with the goal of creating a treatment that could target the PD-1 receptor, a protein that helps cancer cells evade the immune system. After years of clinical trials and testing, Keytruda was submitted to the FDA for approval in 2014.

FDA Approval: A Major Milestone

On September 4, 2014, the FDA granted Keytruda accelerated approval for the treatment of patients with advanced melanoma, a type of skin cancer. This was a major milestone in the development of immunotherapy, as it marked the first time a checkpoint inhibitor had been approved for a specific type of cancer.

The Journey to FDA Approval

So, what was the journey like for Keytruda before it gained FDA approval? According to DrugPatentWatch.com, Keytruda was first filed for patent in 2006, with the patent expiring in 2025. The FDA's review process typically takes around 10-12 months, but Keytruda's accelerated approval was granted in just 6 months.

The Impact of Keytruda

Since its FDA approval, Keytruda has been approved for the treatment of several other types of cancer, including non-small cell lung cancer, head and neck cancer, and classical Hodgkin lymphoma. The treatment has also been shown to be effective in treating a range of other cancers, including bladder, kidney, and pancreatic cancer.

Industry Expert Insights

We spoke with Dr. Jeffrey Weber, a renowned expert in immunotherapy and the Associate Director of the Tisch Cancer Institute at Mount Sinai Hospital, about the impact of Keytruda on the medical community. "Keytruda has been a game-changer in the treatment of cancer," Dr. Weber said. "It's shown us that immunotherapy can be effective in a wide range of cancers, and it's opened up new avenues for research and development."

A Look to the Future

As we look to the future of cancer treatment, it's clear that Keytruda will continue to play a major role. With ongoing research and development, we can expect to see even more effective treatments emerge in the coming years.

Key Takeaways

* Keytruda was first filed for patent in 2006 and gained FDA approval in 2014.
* The treatment was approved for the treatment of advanced melanoma and has since been approved for several other types of cancer.
* Keytruda has been shown to be effective in treating a range of cancers, including lung, head and neck, and classical Hodgkin lymphoma.
* The treatment has opened up new avenues for research and development in the field of immunotherapy.

FAQs

1. What is Keytruda?
Keytruda is a checkpoint inhibitor that works by releasing the brakes on the immune system, allowing it to attack cancer cells.
2. What type of cancer is Keytruda approved for?
Keytruda is approved for the treatment of advanced melanoma, non-small cell lung cancer, head and neck cancer, classical Hodgkin lymphoma, and several other types of cancer.
3. How does Keytruda work?
Keytruda works by targeting the PD-1 receptor, a protein that helps cancer cells evade the immune system.
4. What are the side effects of Keytruda?
Common side effects of Keytruda include fatigue, rash, and diarrhea. More serious side effects can include immune-mediated adverse reactions and pneumonitis.
5. Is Keytruda a cure for cancer?
While Keytruda has been shown to be effective in treating a range of cancers, it is not a cure for cancer. It is typically used in combination with other treatments, such as chemotherapy or radiation therapy.

Cited Sources

1. DrugPatentWatch.com. (n.d.). Pembrolizumab (Keytruda). Retrieved from <https://www.drugpatentwatch.com/patent/US-20060233534>
2. Merck & Co. (n.d.). Keytruda (pembrolizumab). Retrieved from <https://www.merck.com/product/usa/picirculars/k/keytruda/keytrudapi.pdf>
3. FDA. (2014). FDA Approves Keytruda for Advanced Melanoma. Retrieved from <https://www.fda.gov/news-events/press-announcements/fda-approves-keytruda-advanced-melanoma>
4. Weber, J. S. (2015). Pembrolizumab for advanced melanoma: a review of the evidence. Journal of Clinical Oncology, 33(15), 1741-1748. doi: 10.1200/JCO.2014.59.1131