Eli Lilly and Company (LLY - Free Report) announced that the FDA has granted approval to its already approved cancer drug, Cyramza for the second-line treatment of patients with hepatocellular carcinoma (HCC), a common form of liver cancer. Importantly, along with this approval, the FDA has also removed the boxed warning from Cyramza’s label, which included warnings for hemorrhage, ruptured bowel and non-healing wounds.
Lilly’s shares have declined 1.2% this year so far compared with the industry’s decline of 1.6%.
The approval for HCC was based on data from the REACH -2 study, which evaluated the benefit of Cyramza as a single agent in HCC patients who were intolerant to or experienced disease progression after treatment with Amgen (AMGN - Free Report) /Bayer’s (BAYRY - Free Report) Nexavar and also had elevated levels of alpha-fetoprotein (AFP). The results from the REACH – 2 study showed that such patients derived a survival benefit with Cyramza treatment following first-line treatment with Nexavar.
According to Lilly’s press release, approximately 40% of all advanced HCC patients have a high AFP, a marker of poor prognosis. Until now there have been only limited treatment options for HCC patients with increased AFP concentrations, indicating unmet clinical need for the latest approved indication of Cyramza.
Please note that Cyramza is already marketed as a single agent and in combination with another agent as a second-line treatment of advanced or metastatic gastric cancer. It is also approved for use in combination with another agent as a second-line treatment of metastatic non-small cell lung cancer (NSCLC) and metastatic colorectal cancer. The AFP-High HCC indication is the fifth FDA approval for Cyramza in an advanced or metastatic cancer
Cyramza generated revenues of $198.3 million in the recently concluded first quarter of 2019, recording year-over-year increase of 8%. Cyramza is being evaluated in several studies for additional indications, which include a phase III RELAY study for first-line EGFR mutation positive NSCLC.
In March, Lilly announced that the study met the primary endpoint of progression-free survival (PFS). The data from the study showed that treatment with Cyramza in combination with erlotinib significantly delayed disease progression in previously untreated patients with metastatic NSCLC whose tumors have activating EGFR mutations.. Detailed efficacy and safety results from the study will be presented at ASCO in June. Lilly intends to initiate global regulatory submissions in mid-2019.
Lilly currently has a Zacks Rank #3 (Hold). A better-ranked large-cap pharma stock is Merck & Co., Inc. (MRK - Free Report) , which has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Shares of Merck have gained 1% so far this year while estimates for 2019 and 2020 have risen 1.5% and 1%, respectively, over the past 30 days.
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