The return of Clovis as competition for Lynparza:
Clovis Stock Rallies After AstraZeneca-Rivaling Ovarian Cancer Win
Clovis shares were briefly halted shortly after the news, with the stock up 15.2%. Shares rose as high as 46.97 but cooled to a gain of up 10.2% to 41 in afternoon trade.
The stock rammed through a buy zone out of a consolidation formation achieved Dec. 8 from a 40.39 buy point following the announcement. AstraZeneca stock was down 2.6% to 27.14 intraday on the stock market today.
Early Monday, the FDA said it granted accelerated approval to rucaparib, which will be sold under the brand name Rubraca, for women with advanced ovarian cancer who have already been treated by two or more chemotherapies.
The drug is aimed at women whose tumors have a deleterious mutation of the BRCA gene often associated with breast cancer. Women with the mutation have a high risk of developing breast or ovarian cancer, but it's not guaranteed.
According to the National Cancer Institute, an estimated 22,280 women will be diagnosed with ovarian cancer in 2016. Of those, 14,240 will die of the disease. An estimated 15% to 20% have a mutation of their BRCA gene, the Institute says.
Rubraca was studied in two trials of 106 patients, 96% of whom have a confirmed BRCA gene mutation. Of those, 54% experienced partial or complete tumor shrinkage lasting a median of 9.2 months, according to the FDA.
In addition to Rubraca, the FDA approved a companion diagnostic tool to test for the BRCA gene mutation, the FoundationFocus CDxBRCA. The test detects the presence of deleterious BRCA gene mutations. If a mutation is found, a patient may be eligible for Rubraca.
Clovis Stock Rallies After AstraZeneca-Rivaling Ovarian Cancer Win
- ALLISON GATLIN
- 1:40 PM ET
Clovis shares were briefly halted shortly after the news, with the stock up 15.2%. Shares rose as high as 46.97 but cooled to a gain of up 10.2% to 41 in afternoon trade.
The stock rammed through a buy zone out of a consolidation formation achieved Dec. 8 from a 40.39 buy point following the announcement. AstraZeneca stock was down 2.6% to 27.14 intraday on the stock market today.
Early Monday, the FDA said it granted accelerated approval to rucaparib, which will be sold under the brand name Rubraca, for women with advanced ovarian cancer who have already been treated by two or more chemotherapies.
The drug is aimed at women whose tumors have a deleterious mutation of the BRCA gene often associated with breast cancer. Women with the mutation have a high risk of developing breast or ovarian cancer, but it's not guaranteed.
According to the National Cancer Institute, an estimated 22,280 women will be diagnosed with ovarian cancer in 2016. Of those, 14,240 will die of the disease. An estimated 15% to 20% have a mutation of their BRCA gene, the Institute says.
Rubraca was studied in two trials of 106 patients, 96% of whom have a confirmed BRCA gene mutation. Of those, 54% experienced partial or complete tumor shrinkage lasting a median of 9.2 months, according to the FDA.
In addition to Rubraca, the FDA approved a companion diagnostic tool to test for the BRCA gene mutation, the FoundationFocus CDxBRCA. The test detects the presence of deleterious BRCA gene mutations. If a mutation is found, a patient may be eligible for Rubraca.