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FDA Approvals Roundup: Trodelvy and Xolair

Posted 14 April 2021 | By Renee Matthews 

FDA Approvals Roundup: Trodelvy and Xolair

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).

New approvals
Trodelvy approved for advanced triple-negative breast and urothelial cancers
Immunomedics’ Trodelvy (sacituzumab govitecan-hziy) has received regular approval for treating unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) and accelerated approval for locally advanced or metastatic urothelial cancer (mUC), both for patients who have received previous treatment.
The drug was granted regular approval for the mTNBC indication based on efficacy and safety findings from a confirmatory trial that was required after the drug’s April 2020 accelerated approval.
The multicenter, open-label, randomized ASCENT study included 529 patients from the indicated population. They were randomized 1:1 to receive Trodelvy (n = 267) or a single-agent chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine; n = 262) until disease progression or experiencing unacceptable toxicity within a 12-month period. Efficacy endpoints included progression-free survival (PFS) for those with and without brain metastases and overall survival (OS). Median PFS for patients receiving the study drug was 4.8 months, compared with 1.7 months for those receiving chemotherapy alone (hazard ratio, 0.43; P < .0001). Median OS was 11.8 and 6.9 months, respectively, (HR, 0.51; P < .0001).
The review for this indication was conducted under Project Orbis, in collaboration with Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, and Swissmedic. It used the real-time oncology review pilot program and the Assessment Aid.
This application was granted priority review and breakthrough designation.
Trodelvy’s accelerated approval for the mUC indication was based on efficacy and safety findings in the single-arm, multicenter TROPHY trial in 112 patients from the indicated population. Main efficacy endpoints were objective response rate (ORR) and duration of response (DoR). Confirmed ORR was 27.7%, of which 5.4% were complete responses and 22.3% partial responses. Median DoR was 7.2 months (range: 1.4+, 13.7; n = 31).
Continued approval for the indication will depend on follow-up verification and description of clinical benefit in a confirmatory trial.
The review for this indication used the real-time oncology review pilot program and the assessment aid. The application was granted priority review and fast track designations.
New indications
Xolair self-injection with prefilled syringe approved across all indications
Novartis’s Xolair (omalizumab) prefilled syringe for self-injection has been approved as an additional administration option for self-management of all approved indications, which include moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU), and nasal polyps.
Safety protocols stipulate the self-injection option must be initiated and safely established within the clinical setting before a provider can decide if it would be appropriate for the patient or caregiver to continue administration away from this setting. Patients and caregivers must also receive training on correct use and administration of the injection.
Xolair was first approved in 2003 as a subcutaneous injection. In 2018, a single-dose, prefilled syringe formulation was approved for the allergic asthma and CIU indications.
Novartis and Genentech collaborated in the development and marketing of the immunoglobulin E blocker in the US, with Novartis handling all marketing outside of the US.


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Tags: FDA, US

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