Merck Announces FDA Approval of KEYTRUDA Provided to Investors as a Reference
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KEYTRUDA: The first anti-pd-1 therapy approved in the U.S. The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Received FDA Breakthrough Therapy designation for advanced melanoma Rapid execution: Clinical program initiation to FDA approval in ~3.5 years KEYTRUDA embodies Merck s commitment to bring forward breakthrough innovations to help people with the most challenging diseases like advanced melanoma.
U.S. Market Snapshot: Metastatic Melanoma 76,000 Annual Melanoma Diagnoses (any stage) 10,000 Annual Metastatic Melanoma Patients Treatment Pathway Treatment Pathway 5,000 BRAF wild-type Yervoy (possibly followed by Chemo) KEYTRUDA Chemo OR 5,000 BRAF mutated Taf + Mek or Zelboraf Yervoy KEYTRUDA Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through May 2014
Who is being treated for metastatic melanoma today? ~5000 metastatic melanoma patients are being treated each month in the U.S. 25% of these patients may be eligible for treatment with KEYTRUDA based on patients who have previously progressed or those who may progress in the future following treatment with ipilimumab or BRAF inhibitor, if BRAF mutant-positive. Additional patients become eligible over time for treatment with KEYTRUDA due to disease progression on other therapies Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through May 2014
Current U.S. Melanoma Market by Treatment 6,000 5,000 4,000 3,000 2,000 1,000 Total Patients Chemo Yervoy Zelboraf Taf+Mek 0 Source: IMS MTA data, Ipsos Melanoma Monthly Treatment Monitor, Through April 2014
Value of KEYTRUDA KEYTRUDA is the first anti-pd-1 (programmed death receptor-1) therapy approved in the United States and received FDA s Breakthrough Therapy designation for advanced melanoma, which was granted based on the significance of early study findings and the unmet medical need. Access: Merck is committed to making KEYTRUDA accessible to patients. Support for eligible patients is available through Merck Access Program. Merck s patient assistance program can provide free medicine to eligible patients. Price: The wholesale acquisition cost (WAC) for the 50 mg vial (lyophilized) of KEYTRUDA is $2,158. Like other cancer treatments, the total cost of therapy with KEYTRUDA will vary based on patient weight and how long they receive treatment. For most patients, 3 or 4 vials will be used per infusion. The estimated cost for many patients will be approximately $12,500 per month, which is generally consistent with other innovative oncology medicines. Duration: In the patient population described in the label who received KEYTRUDA 2 mg/kg (n=89), the median duration of exposure was 6.2 months (range 1 day to 15.3 months), with a median of nine doses (range 1 to 23).