Breakthrough status for Enhertu in NSCLC

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been granted Breakthrough Therapy Designation (BTD) in the US for the treatment of patients with metastatic non-small cell lung cancer (NSCLC).

The FDA granted BTD based on data from the ongoing Phase II DESTINY-Lung01 trial currently testing Enhertu, a HER2-directed antibody drug conjugate (ADC), in patients with HER2-mutant (HER2m) metastatic NSCLC, and data from the Phase I trial published in Cancer Discovery.

The overall safety and tolerability profile of Enhertu in the ongoing DESTINY-Lung01 trial is consistent with that seen in the Phase I trial.

The most common adverse events to date are gastrointestinal and haematological including nausea, alopecia, anaemia, decreased appetite and decreased neutrophil count.

There have been five cases of drug-related interstitial lung disease (ILD) and pneumonitis in patients with HER2m NSCLC, all of which were Grade 2. There have been no ILD-related deaths.

This is the third BTD granted for Enhertu in the US. Earlier this month, Enhertu received BTD in patients with HER2-positive unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have received two or more prior regimens including trastuzumab.

Enhertu received BTD in 2017 for HER2-positive metastatic breast cancer and received approval in December 2019.

A message from the Editor:

Thank you for reading this story on our news site - please take a moment to read this important message:

As you know, our aim is to bring you, the reader, an editorially led news site but journalism costs money and we rely on advertising and digital revenues to help to support them.

With the Covid-19 lockdown having a major impact on our industry as a whole, the advertising revenues we normally receive, which helps us cover the cost of our journalists and this website, have been drastically affected.

As such we need your help. If you can support our news sites with a small donation of even £1, your generosity will help us weather the storm and continue in our quest to deliver quality journalism.

In the meantime may I wish you the very best.

- Advertisement -

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...

Atomwise announces partnerships to tackle COVID-19

Atomwise, a San Fran company using AI for small molecule drug discovery, has announced it has fifteen research collaborations underway with leading global universities...

GSK secures additional biopharma capacity via Samsung Biologics partnership

GlaxoSmithKline (GSK) has secured additional manufacturing capacity for its biopharmaceutical portfolio by partnering with South Korea’s Samsung Biologics. As per the agreement, Samsung Biologics will...

Related news

Chimeron Bio & NCBID to develop COVID-19 vaccine

RNA therapeutics company, Chimeron Bio, and George Mason University’s National Center for Biodefense and Infectious Diseases (NCBID), will together develop a COVID-19 vaccine. The vaccine...

AbCellera raises $105m to advance antibody drug discovery platform

AbCellera has closed a $105 million Series B financing to further advance its antibody drug discovery platform. The financing was led by OrbiMed and current...

Novavax expands large-scale manufacturing capacity

Novavax, a late-stage biotech developing next-gen vaccines for serious infectious diseases, has expanded its large-scale manufacturing capacity with the $167 million acquisition of Praha...

Gilead & Arcus partner to develop next-gen cancer immunotherapies

Gilead Sciences and Arcus Biosciences, an oncology-focused biopharma working to create best-in-class cancer therapeutics, have entered into a ten-year partnership to co-develop and co-commercialise...