Roche’s lat­est an­ti­body-drug con­ju­gate has crossed the FDA fin­ish line, gain­ing an ac­cel­er­at­ed ap­proval a full two months ahead of sched­ule.

Po­livy, or po­latuzum­ab ve­dotin, is a first-in-class drug tar­get­ing CD79b — a pro­tein promi­nent in B-cell non-Hodgkin lym­phoma. It will now be mar­ket­ed for dif­fuse large B-cell lym­phoma as part of a reg­i­men that al­so in­cludes the chemother­a­py ben­damus­tine and a ver­sion of rit­ux­imab (Rit­ux­an).

The as­so­ci­a­tion with an ag­ing block­buster prod­uct — Rit­ux­an racked up $6.82 bil­lion (6.75 bil­lion CHF) in glob­al sales in 2018 — is rem­i­nis­cent of Kad­cy­la, Roche’s first ADC. A HER2 tar­get­ing treat­ment for metasta­t­ic breast can­cer, Kad­cy­la com­pris­es the best-sell­ing Her­ceptin (trastuzum­ab), which both at­tacks and binds to HER2-pos­i­tive can­cer cells, al­low­ing the chemo agent to be re­leased in­side.

While Rit­ux­an plus chemo can be giv­en as an ini­tial treat­ment, the Po­livy triplet will fill the gap for re­lapsed or re­frac­to­ry cas­es. Of the 18,000 pa­tients di­ag­nosed with DL­B­CL in the US each year, it’s es­ti­mat­ed that 30% to 40% would re­lapse de­spite the pos­si­bil­i­ty of a cure.

Po­livy plus BR have pre­vi­ous­ly demon­strat­ed an over­all sur­vival ben­e­fit in a study of 80 heav­i­ly pre-treat­ed pa­tients, achiev­ing me­di­an OS of 12.4 months com­pared to 4.7 months on BR alone. The com­plete re­sponse rates were 40% and 18% in the drug and con­trol arms, re­spec­tive­ly.

Those re­sults earned the drug — made with ADC tech from Seat­tle Ge­net­ics — a pri­or­i­ty re­view at the FDA in ad­di­tion to break­through and or­phan des­ig­na­tions.

Roche’s Genen­tech is fol­low­ing up with a range of stud­ies in­volv­ing com­bos with its top can­cer ther­a­pies.

“To­day’s ap­proval of Po­livy pro­vides an al­ter­na­tive op­tion for pa­tients in whom mul­ti­ple treat­ments have not worked,” added Richard Paz­dur, di­rec­tor of FDA’s On­col­o­gy Cen­ter of Ex­cel­lence.

Im­age Source: Richard Paz­dur, AACR

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

Thermo Fisher Scientific is putting down more roots in the Bay Area.

The manufacturer opened the doors to a new cell therapy manufacturing facility next to the University of California-San Francisco Medical Center’s Mission Bay campus and on the university’s campus.

UCSF and Thermo Fisher have had a partnership since 2021, with the new site focusing on manufacturing cell therapeutics for certain cancers, including glioblastoma and multiple myeloma. The new site plans to use Thermo Fisher’s expertise in manufacturing services to help UCSF accelerate the development of cell therapies and eventually get them into the clinic, said Dan Herring, the general manager of cell therapy services at Thermo Fisher, in an interview with Endpoints News.

Catalent will be manufacturing a low-cost version of the opioid overdose treatment naloxone as part of a contract with Harm Reduction Therapeutics.

Catalent plans to manufacture the treatment at its facility in Morrisville, NC. No financial details on the deal were disclosed.

Harm Reduction was granted priority review status for the NDA on its spray last year. The company has been working on a naloxone product since 2017. It is anticipating approval in July of this year and a US launch in early 2024.

Last year, South African-based vaccine manufacturer Aspen Pharmacare was facing reports that it had not received a single order for its manufactured Covid-19 shots and that manufacturing lines were sitting idle. But now the vaccine producer is looking to turn things around.

Aspen’s disclosure of its financial results in March unveiled that manufacturing revenue had decreased by 12% to R 603 million ($33.8 million), which Lorraine Hill, Aspen Group’s COO, said is attributable to lower Covid vaccine sales.

Paul McKenzie took over as CEO of Australian pharma giant CSL this month, following in the footsteps of long-time CSL vet Paul Perreault.

With an eye on mRNA, and quickly commercializing its new, $3.5 million-per-shot gene therapy for hemophilia B, McKenzie and chief medical officer Bill Mezzanotte answered some questions from Endpoints News this afternoon about where McKenzie is going to take the company and what advances may be coming to market from CSL’s pipeline. Below is a lightly edited transcript.

Boehringer Ingelheim reported human pharma sales of €18.5 billion on Wednesday, led by type 2 diabetes and heart failure drug Jardiance and pulmonary fibrosis med Ofev. Jardiance sales reached €5.8 billion, growing 39% year over year, while Ofev took in €3.2 billion, notching its own 20.6% annual jump.

However, Boehringer is also looking ahead with its pipeline, estimating “In the next seven years the company expects about 20 regulatory approvals in human pharma.”