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Roche's Lung Cancer Drug Alecensa Gets Approval in China
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Roche Holding AG (RHHBY - Free Report) announced that the China National Drug Administration (CNDA) has approved its lung cancer drug Alecensa (alectinib) as a monotherapy for treating patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer(NSCLC). The approval came on priority review basis in China.
The approval was based on positive results from a global phase III ALEX study and pharmacokinetics results on Asian patients from the phase III ALESIA trial, which compared Alecensa with Pfizer’s (PFE - Free Report) Xalkori in the first-line treatment of ALK-positive NSCLC patients.
Findings from the study demonstrated a long-term progression free survival (PFS) benefit when treated with Alecensa while the median PFS almost trebled to 34.8 months compared with 10.9 months for Xalkori. This nod will further help expanding the patient population for Alecensa significantly with the treatment being previously approved in the second-line setting. This particular data was presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
Alecensa for the first-line treatment is currently being evaluated in two phase II studies for patients, who have progressed on or are intolerant to Xalkori.
Roche’s performance in the first half of 2018 was impressive owing to strong sales of Ocrevus, Perjeta, Tecentriq and Alecensa.
Following this Chinese approval, Alecensa will now be available across more than 57 countries for the first-line treatment of ALK-positive advanced NSCLC including the United States, Europe and Japan. The drug was approved by the FDA and the EMA last November and December, respectively.
However, shares of Roche have lost 4.7% year to date against the industry’s increase of 4.8%.
Bristol-Myers’ earnings estimates have been moved 4.9% north for 2018 and 4.9% for 2019 over the past 60 days.
Illumina’s earnings estimates have been revised 11.1% upward for 2018 and 8.7% for 2019 over the past 60 days. The stock has surged 49.2% so far this year.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
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Roche's Lung Cancer Drug Alecensa Gets Approval in China
Roche Holding AG (RHHBY - Free Report) announced that the China National Drug Administration (CNDA) has approved its lung cancer drug Alecensa (alectinib) as a monotherapy for treating patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer(NSCLC). The approval came on priority review basis in China.
The approval was based on positive results from a global phase III ALEX study and pharmacokinetics results on Asian patients from the phase III ALESIA trial, which compared Alecensa with Pfizer’s (PFE - Free Report) Xalkori in the first-line treatment of ALK-positive NSCLC patients.
Findings from the study demonstrated a long-term progression free survival (PFS) benefit when treated with Alecensa while the median PFS almost trebled to 34.8 months compared with 10.9 months for Xalkori. This nod will further help expanding the patient population for Alecensa significantly with the treatment being previously approved in the second-line setting. This particular data was presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting.
Alecensa for the first-line treatment is currently being evaluated in two phase II studies for patients, who have progressed on or are intolerant to Xalkori.
Roche’s performance in the first half of 2018 was impressive owing to strong sales of Ocrevus, Perjeta, Tecentriq and Alecensa.
Following this Chinese approval, Alecensa will now be available across more than 57 countries for the first-line treatment of ALK-positive advanced NSCLC including the United States, Europe and Japan. The drug was approved by the FDA and the EMA last November and December, respectively.
However, shares of Roche have lost 4.7% year to date against the industry’s increase of 4.8%.
Zacks Rank
Roche currently carries a Zacks Rank #3 (Hold). Two better-ranked stocks in the healthcare sector are Bristol-Myers Squibb Company (BMY - Free Report) and Illumina, Inc. (ILMN - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Bristol-Myers’ earnings estimates have been moved 4.9% north for 2018 and 4.9% for 2019 over the past 60 days.
Illumina’s earnings estimates have been revised 11.1% upward for 2018 and 8.7% for 2019 over the past 60 days. The stock has surged 49.2% so far this year.
Roche Holding AG Price and Consensus
Roche Holding AG Price and Consensus | Roche Holding AG Quote
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