Sunday, August 1, 2021

Subcutaneous Velcade more tolerable in multiple myeloma trial

A phase 2 clinical trial has provided further evidence of the tolerability benefits of giving bortezomib subcutaneously rather than intravenously. The evidence comes from a multiple myeloma trial that tested the proteasome inhibitor in combination with histone deacetylase inhibitor Farydak.

Novartis began a phase 3 trial of Farydak in combination with bortezomib, sold by Takeda as Velcade, in 2009 and went on to initiate another study of the cocktail the following year. However, both the clinical trials used an intravenous formulation of bortezomib. Subsequently, Takeda won approval for a subcutaneous formulation that appeared more tolerable, leading Novartis to initiate a third study in 2016. 

“It was decided to explore different schedules and doses of panobinostat … but in combination with subcutaneous bortezomib, which had really become the standard of care in the utilization of bortezomib between that original randomized study and the opening of PANORAMA 3,” Andrew Spencer, a co-author on the Lancet Oncology paper about the clinical trial, told OncLive.

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.

The latest study found the safety profile of the bortezomib-Farydak combination is better when the proteasome inhibitor is given subcutaneously rather than intravenously. Notably, the incidence of diarrhea was lower in PANORAMA 3 than in Novartis’ earlier clinical trials of the combination.  

Takeda won FDA approval for Velcade for subcutaneous administration in 2012 on the strength of a pivotal trial. The study showed subcutaneous administration is as effective as intravenous delivery and is less likely to cause peripheral neuropathy. Since then, competition has intensified, but Takeda is still positioned to benefit from any increase in interest in the subcutaneous formulation.

Fresenius Kabi won FDA approval for a rival bortezomib product late in 2017. Two years later, the FDA approved another bortezomib product from Dr. Reddy’s Laboratories. Both companies won approval via the 505(b)(2) pathway, rather than the abbreviated new drug application process typically used by generics. The use of the 505(b)(2) pathway led to differences between the labels of Velcade and its two rivals, including the route of administration. The copies were approved for use intravenously. 

Novartis sold the global rights to Farydak to Secura Bio in 2019. 

Source link

Stay Connected


Latest Articles

Need to create vigilance and awareness on zoonotic diseases: India’s Health Minister

The COVID-19 pandemic has highlighted the need of creating vigilance and awareness on zoonotic diseases, informed Union Health Minister Mansukh Mandaviya while virtually inaugurating...

Covid’s second wave proves lethal for pregnant women

At SVP Hospital in Ahmedabad – one of the major Covid-19 hospitals of the city – 148 pregnant women with Covid-19 infection were admitted...

7 Tips to Keep Your Gut Healthy

This is common to say health (and illness) starts in your gut. If you have poor gut health, you’ll experience anything from wrinkled skin, to...

SII making first batch of Covovax: Poonawalla

The first batch of Covovax, a Covid-19 vaccine developed by Novavax Inc, is being manufactured at the Serum Institute of India's Pune facility, SII...

Sputnik V is safest among all Covid-19 vaccines, no deaths recorded: Buenos Aires study

A study by the Buenos Aires Ministry of Health to monitor the safety of the Sputnik V vaccine against Covid-19 confirmed on Thursday that...