Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Lynparza for Ovarian Cancer

FDA news release; 2017 Aug 17

The FDA has approved Lynparza (olaparib) for the maintenance treatment of patients with ovarian cancer.

Indications: Lynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

Dosage and administration: 300 mg taken orally twice daily with or without food.

Efficacy and safety: Approval is based on results of 2 randomized, placebo-controlled, double-blind, multicenter trials which demonstrated statistically significant improvement in progression-free survival in patients receiving Lynparza, vs those treated with placebo.

Side effects/risks: The most common adverse reactions are anemia, nausea, fatigue, vomiting, nasopharyngitis/upper respiratory tract infection/influenza, diarrhea, arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased appetite, constipation, and stomatitis.


FDA approves olaparib tablets for maintenance treatment in ovarian cancer [news release]. Silver Spring, MD: FDA. August 17, 2017. Accessed August 27, 2017.

Lynparza [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. 2017. Accessed August 27, 2017.

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Perioperative radiation therapy underused in elderly patients with soft tissue sarcomas, Venigalla S et al. Intl J Rad Oncology*Biology*Physics; September (102) 2018: 155-165.

Age, R0 resection, and adjuvant radiotherapy boost outcomes in myxofibrosarcoma, Boughzala-Bennadji R et al. Intl J Rad Oncology*Biology*Physics; October (102) 2018: 399-406.

Tumor size, invasion beyond subcutaneous fat predict adverse outcomes in undifferentiated pleomorphic sarcoma, Winchester D et al. J Am Acad Dermatol. Available online 19 May 2018

High recurrence rate after pancreaticoduodenectomy for primary retroperitoneal sarcoma, Tseng W et al. European Journal of Surgical Oncology 2018 (44): June; 810-815.

Nivolumab, pembrolizumab successfully used in Kaposi sarcoma, Galanina et al. Cancer Immunol Res. 2018 Sept 7. doi: 10.1158/2326-6066.CIR-18-0121.

Must Reads in FDA Actions

Nivolumab plus ipilimumab approved for advanced RCC, FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

FDA Approves Lynparza for Certain Types of BC, FDA news release; 2018 Jan 12

Stereotactic Radiotherapy System Approved For BC, FDA news release; 2017 Dec 22

Perjeta Approved for Certain Type of Early BC, Genentech news release; 2017 Dec 20

Varubi Approved for Delayed Nausea and Vomiting, Tesaro news release; 2017 Oct 25