FDA Approves Lenalidomide for Follicular and Marginal Zone Lymphoma

The US Food and Drug Administration (FDA) approved lenalidomide (REVLIMID®, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

Approval was based on two clinical trials: AUGMENT (NCT01938001) and MAGNIFY (NCT01996865). In AUGMENT, 358 patients with relapsed or refractory FL or MZL were randomised (1:1) to receive lenalidomide and rituximab or rituximab and placebo. In the single-arm component of MAGNIFY, 232 patients with relapsed or refractory FL, MZL, or mantle cell lymphoma received 12 induction cycles of lenalidomide and rituximab.

In AUGMENT, the primary endpoint was progression-free survival (PFS) in the intent-to-treat population, as determined by an independent review committee (IRC). Median PFS was 39.4 months (95% CI: 22.9, NE) in the lenalidomide arm and 14.1 months (95% CI: 11.4, 16.7) in the placebo-containing arm (HR 0.46; 95% CI: 0.34, 0.62; p < 0.0001). The objective response rate (ORR) by IRC assessment for patients with follicular lymphoma was 80% (118/147; 95% CI: 73%, 86%) in the lenalidomide arm compared with 55.4% (82/148; 95% CI: 47%, 64%) in the control arm. For patients with marginal zone lymphoma, the ORR by IRC assessment was 65% (20/31; 95% CI: 45%, 81%) compared with 44% (14/32; 95% CI: 26%, 62%), respectively.

In MAGNIFY, the ORR by investigator assessment was 59% (104/177; 95% CI: 51%, 66%) for patients with follicular lymphoma. Median response duration was not reached with a median follow-up of 7.9 months (95% CI: 4.6, 9.2). For patients with marginal zone lymphoma, the ORR by investigator assessment was 51% (23/45; 95% CI: 36%, 66%). Median response duration was not reached with a median follow-up of 11.5 months (95% CI: 8.0, 18.9).

Across both trials, the most common adverse reactions occurring in at least 20% of patients were neutropenia, fatigue, diarrhoea, constipation, nausea, and cough.

The prescribing information includes a Boxed Warning alerting healthcare professionals and patients about the risk of embryo-foetal toxicity, haematologic toxicity, and venous and arterial thromboembolism which may be life-threatening or fatal.

The recommended lenalidomide dose for FL or MZL is 20 mg once daily orally on days 1-21 of repeated 28-day cycles for up to 12 cycles.

Source:https://www.esmo.org/Oncology-News/FDA-Approves-Lenalidomide-for-Follicular-and-Marginal-Zone-Lymphoma

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R...
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that...
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death...
Read more