Cancer, FDA, Regulatory

As generic competition stutter sales of top oncology drugs, Roche secures speedy review for pair of experimental cancer offerings

As drug developers seek ways to expand therapeutic applications and overcome the hurdles seen with the first generation of antibody drug conjugates (ADCs), Roche is capitalizing on its trojan horse ADC — powered by Seattle Genetics’ technology — as generics eat into the sales of its trifecta of top cancer drugs. On Tuesday, the Swiss drugmaker said its anti-CD79b ADC — polatuzumab vedotin — had won the FDA’s priority review for use in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), a field that is within the clutch of CAR-T therapies.

The FDA is expected to make its decision by August 19, Roche said on Tuesday.

Polatuzumab vedotin is being reviewed by the regulator when added to bendamustine and Rituxan (BR). The triplet had previously secured breakthrough therapy status. The priority review was granted on the basis of an 80-patient study in heavily pre-treated subjects that showed the combo eclipsed median overall survival (an exploratory endpoint) compared to BR alone, helping patients live longer by 12.4 months versus 4.7 months. Data also showed 40% of people treated with polatuzumab vedotin plus BR achieved a complete response (CR), while only 18% of people treated with BR alone achieved a CR.

The CD79b protein is expressed in the majority of types of B-cell non-Hodgkin lymphomas, the most common subtype of NHL. Although patients are generally responsive to firstline treatment, as many as 40% of patients relapse, after which options are limited and survival is short. Polatuzumab vedotin, which is being tested for use in several types of NHL, binds to CD79b and decimates B-cells via a targeted approach: minimizing the effects on healthy cells while maximizing tumour cell death, using ADC tech that is sometimes likened to a trojan horse as it is engineered to go unnoticed, delivering chemotherapies to cells expressing the antigen target.

Separately, Roche has also won a priority review for entrectinib, a drug for use in neurotrophic tropomyosin receptor kinase (NTRK) fusion-positive, locally advanced or metastatic solid tumors in patients whose cancer has progressed despite therapy as well as patients with metastatic ROS-1 positive non-small cell lung cancer (NSCLC).

The FDA is expected to make its decision on the drug, which has previously secured breakthrough therapy status, by August 18, Roche said.

Roche, which bagged entrectinib late in 2017 with its $1.7 billion Ignyta buyout, hopes the drug will fare well versus Bayer’s Vitrakvi — the first drug approved by the FDA for NTRK fusion cancers and the runner up ’tissue agnostic’ cancer treatment that won the US regulatory nod. Within NSCLC, entrectinib will be up against Pfizer’s Xalkori, which is the standard treatment in ROS-1 positive patients.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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