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# Product Approval Summaries
- URL: https://www.fdaweb.com/product-approval-summaries-16/
- Published: 2021-09-06T12:00:00.000Z
- Updated: 2026-09-14T17:13:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5140562

**DEVICES**

FDA has approved a **Qiagen** PMA supplement extending the indications for use of the company’s Therascreen EGFR companion diagnostic to guide the use of Boehringer Ingelheim’s targeted therapy Gilotrif (afatinib) for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with non-resistant epidermal growth factor receptor mutations. The approval extends the labeling claim to include detection of EGFR mutations L681Q, G719X and S768I to aid the identification of NSCLC patients for whom Gilotrif (afatinib) is indicated.

FDA has cleared a **Centric Medical** 510(k) for the Cannulated Screw Internal Fixation System for use in foot and ankle reconstruction procedures. The company says the streamlined multi-component system is made of titanium alloy and comes in a variety of diameters and lengths (2.0, 2.5, and 3.0 mm diameters with headed and headless designs). It complements the previously FDA-cleared range of 3.5-7.5mm diameters indicated for the midfoot and hindfoot.

FDA has cleared an **International Biophysics** 510(k) for the FloPump 32 centrifugal disposable heart pump. The company says the single-use device is one of the smallest centrifugal pumps in the world at 32ml prime, and it is intended to be used in conjunction with the Maquet RotaFlow console.

**DRUGS**

FDA approves an **Amgen** supplemental NDA to add overall survival data from the Phase 3 head-to-head ENDEAVOR trial to the prescribing information for Kyprolis (carfilzomib). The data demonstrated that Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall summary by 7.6 months versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma.

FDA has expanded the approved use of **AstraZeneca**’s Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have metastasized and whose tumors have a specific genetic mutation. The agency says it is the first PARP inhibitor approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment based on genetic testing using Myriad Genetic Laboratories’ BRACAnalysis CDx. Lynparza was first approved in 2014 to treat certain patients with ovarian cancer.