Lartruvo▼ (olaratumab): no new patients to be prescribed due to study showing no clinical benefit
In January 2019,
, indicated for advanced soft tissue sarcoma, to announce that, following the results of a clinical trial (ANNOUNCE) showing no survival benefit:
- no new patients should be prescribed Lartruvo
- while further assessment of the study results is ongoing, treatment with Lartruvo may continue in patients who experience clinical benefit
Lartruvo is indicated in combination with doxorubicin for the treatment of adult patients with advanced soft tissue sarcoma who are not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin. Continued approval is contingent upon verification of clinical benefit in the confirmatory trial ANNOUNCE.
The global phase 3 study (ANNOUNCE) of Lartruvo in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS) did not show benefit in terms of survival and progress-free survival compared with doxorubicin, a standard of survival care treatment. See the letter for the study data.
Other letters sent to healthcare professionals
In January 2019 the below letters were also sent to healthcare professionals:
: risk of Fournier’s gangrene (necrotising fasciitis of the perineum)
: (1) risk of acute pancreatitis and (2) strengthened advice on contraception]
Class 2 Medicines Recall: Actavis Group PTC EHF - recall of batches of Irbesartan/Hydrochlorothiazide 300/12.5mg Film-coated Tablets and Irbesartan/Hydrochlorothiazide 150/12.5mg Film-coated Tablets. Issued 3 January 2019. Actavis Group PTC EHF is recalling the listed batches from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).
Class 2 Medicines Recall: Macleods Pharma UK Limited - Irbesartan 150mg Film-coated tablets, PL 34771/0079 (MDR 94-06/18). Issued 21 January 2019. Macleods Pharma UK Limited is recalling the listed batches from pharmacies as a precautionary measure due to possible contamination with N-nitrosodiethylamine (NDEA).
Article citation: Drug Safety Update volume 12, issue 7: February 2019: 4.
Published 18 February 2019