Voluntary Announcement Olaparib Tablets Obtains Drug Registration Approval
Tango Therapeutics said Thursday it has stopped development of an early-phase synthetic lethal cancer candidate after seeing liver toxicity in recipients of the molecule.
New Delhi: The Drug Controller General of India has asked drug regulators in all states and Union territories to withdraw AstraZeneca's anti-cancer drug Olaparib tablets for treatment in patients who have received three or more prior lines of chemotherapy. State regulators have been asked to direct manufacturers of the drug to discontinue marketing of the drug for the treatment of patients with gBRCA mutation and advanced ovarian cancer and breast cancer due to potential adverse effects and submit the revised package insert.
In December, when Merck revealed that Lynparza didn’t add benefits to Keytruda in certain non-small cell lung cancer (NSCLC) patients, the trial appeared to be a complete failure. Although the study itself is beyond salvaging, detailed data now raise some hope for the combination in the future.
Merck Provides Update on Phase 3 KEYLYNK-006 Trial Evaluating KEYTRUDA® (pembrolizumab) Plus Maintenance LYNPARZA® (olaparib) for Certain Patients With Metastatic Nonsquamous Non-Small Cell Lung Cancer
AstraZeneca Shows Lynparza Combo Could Address Unmet Endometrial Cancer Need
Zydus launches anti-cancer generic drug olaparib in India
Merck halts trial after Keytruda-Lynparza combo flunks PhIII study in lung cancer
WILMINGTON, Del.--(BUSINESS WIRE)--Positive results from the primary analysis of the DUO-E Phase III trial showed that IMFINZI® (durvalumab) plus platinum-based chemotherapy, followed by either IMFINZI monotherapy or IMFINZI plus LYNPARZA® (olaparib), both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone in the overall trial population of patients with newly diagnosed advanced or recurrent endometrial cancer.