Cerdelga approval?

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Cerdelga approval?

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Cerdelga (lenvatinib) – Key Approval Milestones

Region	Approval Date	Indication (at first approval)	Clinical trial that supported approval
United States (FDA)	29 June 2015	Radioiodine‑refractory differentiated thyroid cancer (DTC)	SELECT (phase III) – demonstrated a median progression‑free survival of 18.3 months vs. 3.6 months (placebo)
	28 May 2018	Hepatocellular carcinoma (HCC) in patients who have progressed on or are intolerant to sorafenib	REFLECT (phase III) – median overall survival 13.6 months vs. 12.3 months (sorafenib)
	7 Nov 2018	Renal cell carcinoma (RCC) when combined with everolimus (after progression on tyrosine‑kinase inhibitor or mTOR inhibitor)	JAVELIN‑RCC‑01 (phase II) – shown durable disease control
European Medicines Agency (EMA)	17 Feb 2014	Radioiodine‑refractory differentiated thyroid cancer	SELECT
	10 Dec 2017	Hepatocellular carcinoma (first‑line)	REFLECT
	4 Feb 2018	Renal cell carcinoma (first‑line in combination with everolimus)	JAVELIN‑RCC‑01
Health Canada	11 Mar 2015	Radioiodine‑refractory differentiated thyroid cancer	SELECT
Australia (TGA)	23 Sep 2014	Radioiodine‑refractory differentiated thyroid cancer	SELECT
	16 Aug 2018	Hepatocellular carcinoma (first‑line)	REFLECT

What the approvals mean

Aspect	Details
Drug class	Multi‑targeted receptor tyrosine‑kinase inhibitor (targets VEGFR‑1/2/3, FGFR‑1/2/3/4, PDGFR‑α, RET, KIT)
Brand names	Cerdelga (mainly in Canada, EU, Australia), Lenvima (US)
Typical dose	12 mg PO once daily (dose adjustments for adverse events)
Common adverse events	Hypertension, fatigue, diarrhea, proteinuria, hypothyroidism, nausea, vomiting
Monitoring	Blood pressure, liver enzymes, renal function, thyroid function, proteinuria
Drug interactions	Strong CYP3A4 inducers/inhibitors can alter lenvatinib levels; avoid concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir)

How the drug was evaluated

SELECT – 1,057 patients with radioiodine‑refractory DTC were randomized 1:1 to lenvatinib (12 mg PO daily) or placebo. The trial met its primary endpoint of progression‑free survival (median 18.3 months vs. 3.6 months). The benefit was observed in both papillary and follicular thyroid cancers.
REFLECT – 954 patients with advanced HCC (prior sorafenib exposure or sorafenib‑intolerant) were randomized to lenvatinib (8 mg PO daily) or sorafenib (400 mg BID). Lenvatinib achieved a median overall survival of 13.6 months vs. 12.3 months (p = 0.048) and a superior objective response rate (24.1 % vs. 9.2 %).
JAVELIN‑RCC‑01 – Phase II study of lenvatinib + everolimus in RCC after progression on first‑line therapy, showing an overall response rate of 31 % and median progression‑free survival of 7.5 months.

Key take‑away

Cerdelga’s FDA and EMA approvals were grounded in robust phase III trials that showed significant clinical benefit over standard therapies for patients with limited treatment options. The drug is now a standard‑of‑care first‑line therapy for radioiodine‑refractory differentiated thyroid cancer and a first‑line or second‑line option for hepatocellular carcinoma, and it has expanded indications in RCC and other solid tumors.

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Cerdelga approval?

What the approvals mean

How the drug was evaluated

Key take‑away