Lynparza’s New Tablet Formulation Receives FDA Approval For Ovarian Cancer

Lynparza’s New Tablet Formulation Receives FDA Approval For Ovarian Cancer

A new formulation of Lynparza (olaparib) tablets received FDA approval to prevent disease progression and relapse in ovarian cancer patients. The new tablets allow patients previously taking the drug in capsule form as a part of maintenance therapy to reduce their daily intake from eight capsules per day to two tablets per day, regardless of BRCA mutations.

Lynparza inhibits the poly ADP-ribose polymerase (PARP) and kills cancer cells, which are more sensitive to its DNA-damaging effects. After its approval in 2014, more than 3,000 women with advanced ovarian cancer have been treated with Lynparza. But even after the initial treatment, patients must maintain the treatment to prevent disease progression or relapse.

The FDA approval followed the results of two trials, SOLO-2 Phase III trial (ClinicalTrials.gov, number NCT01874353) and Study 19 Phase II trial (ClinicalTrials.gov, number NCT00753545). SOLO-2 enrolled 295 women with BRCA-mutated relapsed serous ovarian cancer who received Lynparza after responding to at least two treatments of platinum-based chemotherapy.

Women who took Lynparza tablets (300mg twice a day) showed a 70% reduced risk of disease progression or death. In this study, patients’ time to disease progression was 19.1 months compared to 5.5 months in women who received placebo. SOLO-2 strengthened study 19 results, which already showed that ovarian patients treated with Lynparza as maintenance therapy reduced risk reduction of disease progression or death by 65%.

“Today’s approval demonstrates that olaparib is an effective option for maintenance therapy for certain ovarian cancer patients, regardless of BRCA status,” said Richard Penson, MD, clinical director of medical gynecologic oncology at Massachusetts General Hospital Cancer Center, associate professor of medicine at Harvard Medical School, and the primary investigator in the SOLO-2 trial.  “We welcome this news in the ovarian cancer community as more options are important to help us ensure that patients can find a treatment that is right for them.”

There are no contraindications for Lynparza but both studies detected adverse reactions such as anemia, headache, decreased appetite, and constipation in ≥20% of the patients. Importantly, Lynparza tablets and capsules are not the same and should not be interchanged.

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