Plus CAR-T safety, Seagen, J&J, Roche, bluebird and more

 

The American Society of Hematology’s annual meeting was made special by the FDA’s landmark approvals of two sickle cell gene therapies and its ongoing investigation into CAR-T cancer risks. Besides stories on those topics, we report here on hopes for combining an ADC with a PD-1 drug, a new standard of care in first-line multiple myeloma, bispecific showdowns and more.

Top Stories

Abecma’s survival data show why FDA wanted expert meeting on the Bristol Myers cell therapy

By Angus Liu

Bristol Myers' CAR-T therapy Abecma showed no advantage in overall survival compared with standard combination regimens in an earlier treatment setting of multiple myeloma. The FDA is slated to dissect the data at an upcoming advisory committee meeting.

Pfizer, swimming in crowded waters, eyes wide impact for sickle cell, hemophilia assets

By Annalee Armstrong

Novo Nordisk and Pfizer are not going head-to-head in hemophilia. But they are, at least, racing side-by-side to bring an anti-tissue factor pathway inhibitor to market to provide a better treatment experience for patients.

Seagen's Adcetris and Bristol's Opdivo boost hopes for another ADC, PD-1 combo

By Angus Liu

After BMS' Opdivo topped Seagen's classical Hodgkin lymphoma therapy Adcetris in a head-to-head trial, Seagen has trotted out new data suggesting the two drugs—a PD-1 inhibitor and an antibody-drug conjugate—hold potential when paired together.

J&J, Sanofi square off in newly diagnosed multiple myeloma, with one med showing 'unprecedented' efficacy

By Angus Liu

Another data face-off between the two anti-CD38 multiple myeloma drugs—J&J's Darzalex and Sanofi's Sarclisa—took place at the ASH conference. Both regimens showed strong efficacy in newly diagnosed patients, but only one result is considered practice-changing right now.

After Imbruvica's stumble in mantle cell lymphoma, AbbVie and J&J eye possible combo comeback

By Fraiser Kansteiner

With the initial shock of AbbVie and Johnson & Johnson's disease-specific approval pull for Imbruvica now fading into the rearview, the partners are making the case for the BTK inhibitor to stage a comeback in mantle cell lymphoma.

Bluebird’s sickle cell gene therapy comes with safety warning and higher price. Can Lyfgenia overcome CRISPR’s halo?

By Angus Liu

Alongside a historic approval for the first therapy utilizing the Nobel Prize-winning CRISPR/Cas9 gene-editing technology, the FDA has cleared a rival gene replacement therapy, also for sickle cell disease (SCD).

After landmark FDA approvals, Editas still thinks its gene therapy differentiates itself enough from competition

By Gabrielle Masson

On the heels of Friday’s FDA approval of not one but two gene therapies to treat sickle cell disease, Editas Medicine is sharing another slice of early data for its gene-edited candidate designed to tackle the same condition.

Regeneron’s ELM stands tall, with near-approval bispecific shining again in updated lymphoma data

By Nick Paul Taylor

Regeneron has brought its bispecific antibody odronextamab through another test, presenting updated data on the lymphoma candidate ahead of an FDA approval decision that is scheduled for March 31.

Regeneron touts possible 'best-in-class' myeloma bispecific, but adverse events climb to 100%

By Eric Sagonowsky

Responses to Regeneron's bispecific linvoseltamab have risen but so have adverse events and deaths associated with the multiple myeloma drug.

Roche offers glimpse of Columvi-Polivy combo's early lymphoma data as phase 3 kicks off

By Angus Liu

As Roche’s blood cancer portfolio booms with new life thanks to the antibody-drug conjugate Polivy and bispecifics, the company is offering a look at data for two combinations of those drugs that support two phase 3 trials in diffuse large B-cell lymphoma.

As FDA puts CAR-T safety under microscope, researchers dig into adverse events record of BCMA therapies

By Angus Liu

A new study examined side effect reports of BMCA immunotherapies from the FDA Adverse Event Reporting System, hoping to help inform doctors in their treatment decisions.

With high tumor response, AstraZeneca spinout Dizal explores FDA path and US partner for PTCL drug

By Angus Liu

Just as the FDA revisits two accelerated approvals in peripheral T cell lymphoma (PTCL), AstraZeneca spinout Dizal Pharmaceutical is charting its own path for a potential conditional nod in the blood cancer.

As Novartis enters PNH market, AstraZeneca shows longer term effect of its latest contender

By James Waldron

The week after Novartis secured a foothold in the paroxysmal nocturnal hemoglobinuria (PNH) market, AstraZeneca has released new data from its own attempt to find fresh ways of tackling this rare blood disease.

Rare disease biotech Electra picks commercially-minded Kathy Dong as next CEO

By Annalee Armstrong

Electra Therapeutics is several years away from having a commercial product. And yet, the biotech’s new CEO Kathy Dong’s resume is stacked with experience on marketing and launching drugs—most notably, Gilead’s Sovaldi and Harvoni.