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Merck's Keytruda Gets FDA Nod For Expanded Use In Lung Cancer

The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey, U.S., July 12, 2018. REUTERS/Brendan McDermid/File Photo Acquire Licensing Rights

Oct 16 (Reuters) - The U.S. Food and Drug Administration on Monday approved the expanded use of Merck & Co's (MRK.N) blockbuster immunotherapy Keytruda in early-stage patients with non-small cell lung cancer who can get their tumors removed surgically.

The U.S. Health regulator's approval extends Keytruda's use in combination with chemotherapy as a treatment given before surgery to shrink the size of the tumor in patients.

The decision also allows use of the drug as a follow-up treatment after surgery.

The U.S. Drugmaker is aiming to widen use of Keytruda, used as a second line of treatment in some cancer patients, into earlier lines of treatment.

The drug, which is set to lose certain U.S. Patents towards the end of the decade, had sales of $12.1 billion in the last two quarters.

Merck's application to the agency for expanded use was based on data from a late-stage trial in which Keytruda met one of the dual primary study goals of event-free survival (EFS), or the period of time a patient remains free of disease and related complications.

Keytruda, Merck's top-selling product approved in multiple indications worldwide, helps the body's own immune system fend off cancer by blocking a protein called PD-1.

Positive overall survival data should boost Keytruda's uptake in the peri-operative setting ... And that approval in this setting was an attractive commercial opportunity, Citeline analyst Ellie Davenport said.

Morningstar analyst Damien Conover expects the early-line lung cancer setting to be competitive with Bristol-Myers Squibb's (BMY.N) Opdivo, Roche's (ROG.S) Tecentriq and AstraZeneca PLC (AZN.L) Imfinzi, all looking to gain approvals in the early-stage setting.

Conover expects strong use of Keytruda in the earlier-line lung cancer setting, given the very strong efficacy.

The drug is already approved as a follow-up treatment for adult patients with early stages of NSCLC after chemotherapy and surgery.

Earlier in October, Merck reported that Keytruda also met its second primary goal of overall survival among NSCLC patients in the late-stage study, building its case for use of the drug in the patient population.

The Keytruda/chemotherapy combination, when given before surgery, helped patients live longer without the disease compared to only chemotherapy.

Merck, earlier in the day, also reported that the European Commission has approved Keytruda as a follow-up treatment for adult NSCLC patients who are at a high risk of the disease returning after complete resection and chemotherapy.

Reporting by Shivani Tanna and Pratik Jain in Bengaluru; Editing by Shinjini Ganguli, Shailesh Kuber and Sherry Jacob-Phillips

Our Standards: The Thomson Reuters Trust Principles.


Merck Therapy Shows Improved Survival In Certain Kidney Cancer Patients

Merck (NYSE:MRK) announced on Wednesday positive trial result for its KEYTRUDA (pembrolizumab) anti-PD-1 therapy.

KEYTRUDA is an immunotherapy that may treat certain cancers by working with the immune system. In a Phase 3 KEYNOTE-564 trial, the therapy met its secondary endpoint of improvement in overall survival (OS) compared to placebo in patients with renal cell carcinoma at a higher risk of recurrence following surgery.


DCGI Approves MSD's Drug Keytruda For The Treatment Of Triple Negative Breast Cancer And Renal Cell Carcinoma

MSD (known as Merck in the US and Canada) recently announced that the Drugs Controller General of India (DCGI) has approved Keytruda (pembrolizumab), MSD's anti-PD-1 therapy, for the treatment of triple-negative breast cancer (TNBC) and renal cell carcinoma (RCC) in adults. Keytruda has been approved for high-risk early-stage and metastatic triple-negative breast cancer for select patients who are at a high risk of recurrence. With this approval, Keytruda is now the first immunotherapy approved for the adjuvant treatment of certain patients with renal cell carcinoma and early stage triple-negative breast cancer. Keytruda is an immunotherapy that works with the immune system to help fight cancer cells. It is different from chemotherapy or radiation therapy. The immune system sends certain types of cells called T-cells throughout your body to detect and fight infections and diseases—including cancer. Cancer cells may use the PD-1 pathway to hide from T-cells. This stops T-cells from attacking cancer cells and allows cancer cells to grow and spread. Keytruda blocks the PD-1 pathway to help prevent cancer cells from hiding. Keytruda helps the immune system to detect and fight cancer cells. Commenting on the approval, Rehan A Khan, managing director, MSD India said, "At MSD, we are committed to improving access to high-quality medicines that significantly improve health outcomes. With these approvals, Keytruda has become an important treatment option in India and now is approved for 14 indications across 8 different types of tumours." He further added, "Timely access to new and innovative treatment strategies for cancer patients is essential in improving the quality of care, and alleviating the burden of cancer on the economy, society and the wider community in India." TNBC is the most aggressive type of breast cancer, which has the highest risk of recurrence within the first five years after diagnosis and is associated with worse outcomes compared to other forms of breast cancer. RCC is by far the most common type of kidney cancer. RCC is about twice as common in men than in women. Despite decades of research, limited treatment options are available for treatment of RCC which is often at risk of recurrence. This approval will address a critical unmet need for select patients. Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Keytruda is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumour cells and healthy cells. For 130 years, MSD, known as Merck in the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, MSD continues to be at the forefront of research to prevent and treat diseases including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases.





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