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Articles

Safety in Lactation: Drugs affecting gonadotrophins

17 September 2020The most common use of these drugs in women is for endometriosis, the symptoms of which may be supressed during pregnancy and while breastfeeding. The…
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Lactation Safety Information

Buserelin
No published evidence of safety
Negligible levels anticipated in milk, due to drug’s properties, with subsequent minimal absorption from the infant’s GI tract
18 September 2020

New Medicines

Camcevi Prostate cancer - treatment - 6-monthly depot formulation

Information

Camcevi
New formulation
Accord Healthcare Ltd
Accord Healthcare Ltd

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Approved (Licensed)
May 21Approved in US; Camcevi is exclusively licensed to Accord BioPharma for US commercialisation [10].
Oct 20FDA accepts the re-submission. The goal date under the Prescription Drug User Fee Act (PDUFA) is May 27, 2021 [9].
Jul 20Foresee re-submits to the FDA a New Drug Application for CAMCEVI 42MG (FP-001 LMIS 50mg), a ready-to-use 6-month depot formulation of leuprolide mesylate. The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer. The submission is supported by a PIII study in 137 advanced prostate carcinoma patients, where treatment with LMIS 50 mg injection every 6 months was demonstrated to be effective, safe and well tolerated. In the NDA submission in 2019, FDA suggested that additional device design verification data on the combination product be provided [8].
Apr 20Forsee has an agreement with Accord for leuprorelin depot. Accord Healthcare will cover all costs of commercialisation in the global market with the exception of the USA, China, Japan, Taiwan and previously partnered territories, Israel, Turkey and certain Middle East countries [7].
Apr 20Filed in EU via centralised procedure [6].
Mar 19Forsee plans to establish a partnership with a strong commercial player that will successfully launch our FP-001/LMIS franchise in the US; assume they will also plan to do this in the EU [5].
Mar 19Foresee files a NDA to the US FDA for LMIS 50mg, a ready-to-use 6 month depot formulation of leuprolide mesylate, for the palliative treatment of advanced prostate cancer [4].
Feb 17Foresee Pharmaceuticals plan to submit MAA in Germany and follow the decentralized procedure for registration in Europe. Also plan to submit an application in the US [1].

Category

Gonadotropin-releasing hormone (GnRH) stimulant; a peptide injectable, controlled-release, 6-month depot formulation of leuprorelin (leuprolide mesylate)
The age-standardised incidence of prostate cancer in the UK in 2014 was 175 per 100,000 population
Prostate cancer - treatment - 6-monthly depot formulation
Subcutaneous

Trial or other data

Feb 19Foresee announces that the PIII registration trial met its primary efficacy endpoint of suppression of serum testosterone (= 50ng/dl) by day 28 and from day 28 to day 168 in the intent-to-treat (ITT) population. The study evaluated the safety, efficacy and pharmacokinetics of leuprolide mesylate injectable suspension (LMIS) (25mg; 3-month depot version), in patients with prostate cancer (NCT03261999) [4].
Jul 18PIII study to evaluate the safety, efficacy and pharmacokinetics of leuprolide mesylate injectable suspension, in patients with prostate cancer has finished recruitment of 144 patients in the US, Czech Republic, Lithuania, South Korea and Slovakia (NCT03261999) [3].
Dec 17PIII safety extension trial to further assess the safety, efficacy and pharmacokinetics of controlled-release peptide formulation of leuprorelin in 30 patients in the US with advanced prostate cancer and who completed 12 months of leuprorelin 50mg treatment under Protocol FP01C-13-001 completes (FP01C-13-001-EX; NCT02712320) [2].
Jan 17Foresee Pharmaceuticals reported that the PIII trial met its primary efficacy endpoint in 97% of patients with advanced prostate cancer (FP01C13-001; EudraCT2013-001790-25; NCT02234115). The trial, that was completed in September 2016, assessed the safety, efficacy and pharmacokinetics of a subcutaneous controlled-release peptide formulation of leuprorelin for the treatment of advanced prostate cancer. The trial was initiated in August 2014. The open-label trial enrolled 133 patients in the US, Taiwan and select countries in the EU, including Germany and Austria (not UK). An extension trial is planned [1].