2024-09-23 14:07:00
EMA approves AstraZeneca’s Lynparza and Imfinzi
After refusing AstraZeneca’s early access request last May, the EMA has finally approved Lynparza (olaparib) and Imfinzi (durvalumab) in endometrial cancer. Imfinzi will thus be authorized in Europe, combined with carboplatin and paclitaxel, in the first-line treatment of the disease. For its part, Lynparza will be indicated, in combination with durvalumab, as maintenance treatment. This decision follows the granting of a favorable opinion by the CHMP issued on June 27. Endometrial cancer is the 4th leading cause of cancer in women in France, and the most common gynecological cancer. Mainly affecting postmenopausal women, it affected 420,000 new patients worldwide in 2022, resulting in nearly 98,000 deaths. The British laboratory’s second best-selling oncology drug, Imfinzi, already approved for the treatment of lung cancer and advanced biliary tract cancer, obtained FDA approval for endometrial cancer last May.
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Gilead’s Sunlenca Sees New Positive Results Against HIV
The American laboratory announced the preliminary results of a second pivotal phase III trial evaluating Sunlenca (lenacavir) in the prevention of HIV. After obtaining positive results in June in a first phase III study involving only women, the drug has this time reduced infections by 96% in men and transgender people in particular. Injectable twice a year, Sunlenca has also demonstrated its superiority compared to Truvada (emtricitabine/tenofovir), the reference drug administered daily, and marketed by Gilead for twelve years. The laboratory would like to begin ” a series of global regulatory filings by the end of 2024 ».
Boehringer Ingelheim achieves positive phase III results
In a Phase III trial evaluating its efficacy in the treatment of idiopathic pulmonary fibrosis (IPF), Boehringer Ingelheim’s nerandomilast met its primary endpoint of improving lung function. The drug had already been granted Breakthrough Therapy Designation for IPF in 2022. Although considered a ” rare “, IPF affects approximately 3 million people worldwide, with a greater impact on men over 50. The laboratory intends to submit an application for authorization to the FDA soon, as well as to ” other health authorities around the world ».
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