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Exelixis, Ipsen Get EU Nod for Label Expansion of Cabometyx

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Exelixis, Inc. (EXEL - Free Report) and partner Ipsen received approval from the European Commission (EC) for the label expansion of Cabometyx (cabozantinib) tablets. Cabometyx tablets are approved as a monotherapy for hepatocellular carcinoma (HCC) in adults who have previously been treated with Bayer’s (BAYRY - Free Report) Nexavar (sorafenib). This approval allows marketing of Cabometyx in this indication in all 28 member states of the European Union, Norway and Iceland.

We note that Cabometyx is already approved in the United States for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy. It is also approved in Europe for the first-line treatment of adults with intermediate- or poor-risk advanced RCC in the European Union.

The approval is supported by data from the phase III CELESTIAL study of Cabometyx in patients with advanced HCC who received Nexavar previously. In this study, Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) against placebo.

Per the collaboration agreement with Ipsen, Exelixis is eligible to receive a milestone payment of $40 million for the approval of the second-line treatment of HCC. This milestone would be paid by Ipsen within the next 70 days of approval.

Shares of Exelixis decreased 44.9% year to date compared with the industry’s decline of 20.7%.

 

 

In September 2018, the National Comprehensive Cancer Network (NCCN) updated its Clinical Practice Guidelines to include new recommendations for Cabometyx. Following the update, Cabometyx is now recommended by the NCCN for treating advanced RCC, regardless of patient risk status (favorable-, intermediate- and poor-risk).

Moreover, the NCCN in its recent update on the Clinical Practice Guidelines for Hepatobiliary Cancers added Cabometyx as a Category 1 option for the treatment of patients with HCC (Child-Pugh Class A only) who have been previously administered with Nexavar.

In May 2018, the FDA accepted the supplemental new drug application for Cabometyx in previously treated advanced HCC and assigned it with a Prescription Drug User Fee Act action date of Jan 14, 2019.

We remind investors that in September 2018, the company along with Ipsen received Canadian approval for Cabometyx tablets for the treatment of advanced RCC in adult patients who have been previously treated with vascular endothelial growth factor targeted therapy.

Cabometyx generated $158.3 million of net product revenues in the third quarter of 2018.

Exelixis, Inc. Price

Zacks Rank & Other Stocks to Consider

Exelixis is a Zacks Rank #2 (Buy) stock.

Some other top-ranked stocks worth considering are Bristol-Myers Squibb Company (BMY - Free Report) and Eli Lilly and Company (LLY - Free Report) . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.59 to $3.84 for 2018 and from $3.83 to $4.07 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 11.99%.

Lilly’s earnings per share estimates have increased from $5.42 to $5.53 for 2018 and from $5.65 to $5.80 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 10.03%. Shares of the company have increased 30% year to date.

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