Editors' (re)View: Landmark approval for solid tumors; Relief for food allergy sufferers 

Feb. 23, 2024
Pharma Manufacturing editors Karen Langhauser and Andrea Corona comment on the notable happenings in the pharma industry from the week of February 19

Landmark approval for solid tumors 

The U.S. FDA's accelerated approval of Iovance Biotherapeutics' Amtagvi (lifileucel) this week marked a groundbreaking advancement in cancer therapies as we know them.

Not only is it the first-ever T-cell therapy for a solid tumor cancer, its also the first treatment option for advanced melanoma following anti-PD-1 and targeted therapy, offering hope for patients with limited options, showcasing the potential for innovative immunotherapies to revolutionize cancer care.

With promising overall response rates and duration of response observed in clinical trials, Amtagvi exemplifies the potential of precision medicine in oncology, heralding a new era of targeted and personalized cancer therapies.

As researchers continue to explore and refine immunotherapeutic approaches, Amtagvi's approval marks a pivotal moment in the journey towards more effective, less toxic, and ultimately, lifesaving treatments for cancer. — Andrea Corona 

Xolair helps food allergy sufferers breathe a sigh of relief

With this week’s exciting news about Iovance’s Amtagvi approval as the first solid tumor T-cell therapy, other approvals got a little lost in the shuffle. To that end, I wanted to circle back to Xolair’s food allergy nod.

Seeing how indiscriminate my nieces and nephews can be about what they stick in their mouths (did that kid just eat a random piece of candy off the airport floor?), I can’t imagine how terrifying it must be to have a child who runs the risk of a life-threatening reaction if they accidentally eat the smallest amount of certain common foods. 

There are 160 different foods that can cause the most common type of allergic reaction, known as immunoglobulin E (IgE)-mediated food allergies. About 3.4 million kids and 13.6 million adults in the U.S. have been diagnosed with IgE-mediated food allergies.

The recent Roche-Novartis approval for Xolair was based on results from the NIH-sponsored phase 3 OUtMATCH study. In the study, a portion of food allergy patients as young as 1 year treated with Xolair — which was first approved over 20 years ago to treat asthma — were able to tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction.

More specifically, of those who received Xolair, 68% were able to eat the single dose of peanut protein (equivalent to 2.5 peanuts) without moderate to severe allergic symptoms.

While the drug will not eliminate food allergies, its use (every 2 to 4 weeks) will help reduce a potentially fatal outcome in the event of accidental exposure, which has to be a huge relief for allergy sufferers (and parents of allergy sufferers) and a great step forward for managing food allergies. —Karen Langhauser

About the Author

Karen P. Langhauser | Chief Content Director, Pharma Manufacturing

Karen currently serves as Pharma Manufacturing's chief content director.

Now having dedicated her entire career to b2b journalism, Karen got her start writing for Food Manufacturing magazine. She made the decision to trade food for drugs in 2013, when she joined Putman Media as the digital content manager for Pharma Manufacturing, later taking the helm on the brand in 2016.

As an award-winning journalist with 20+ years experience writing in the manufacturing space, Karen passionately believes that b2b content does not have to suck. As the content director, her ongoing mission has been to keep Pharma Manufacturing's editorial look, tone and content fresh and accessible.

Karen graduated with honors from Bucknell University, where she majored in English and played Division 1 softball for the Bison. Happily living in NJ's famed Asbury Park, Karen is a retired Garden State Rollergirl, known to the roller derby community as the 'Predator-in-Chief.' 

About the Author

Andrea Corona | Senior Editor