Provenge to remain available during Dendreon bankruptcy

According to a media release issued by Dendreon Corp. early this morning, the company will be declaring Chapter 11 bankruptcy but is assuring physicians and patients that sipuleucel-T (Provenge) will continue to remain available during the company’s restructuring. What is a good deal less clear is whether the company will be sold after the restructuring or will continue to operate as a stand-alone entity.

NICE rejects Provenge as a treatment for mCRPC based on cost

The National Institute for Health and Clinical Excellence (NICE) in the UK has issued a statement that, according to preliminary draft guidelines, it has rejected the use of sipuleucel-T (Provenge) to treat patients with metastatic prostate cancer before they have received chemotherapy. … READ MORE …

Dendreon to make sipuleucel-T available in Germany, the UK

According to a media release issued earlier today, Dendreon is planning to make sipuleucel-T (Provenge) available in Europe, beginning with Germany and the United Kingdom. However, the media release is short on any precision regarding the dates of such availability. … READ MORE …

“Immunotherapy for prostate cancer: past, present, and future”

An article with the above title by Dr. Michael Glodé (a well-known medical oncologist at the University of Colorado in Denver) appears in the most recent issue of ASCO Connection. … READ MORE …

Can Dendreon continue on its own?

According to a report on the Bloomberg.com web site, Dendreon “is seeking a buyer after sales of its prostate-cancer treatment failed to meet expectations.” The “New” Prostate Cancer InfoLink has no “inside scoop” on this, but it would be a terrible shame if such an innovative approach to cancer therapy were to go off the market.

Provenge likely to be approved in Europe later this year

The European Medicines Agency’s Committee for Medicinal Products for Human Use today recommended that marketing authorization be approved for sipuleucel-T (Provenge) in the European Union. A final decision by the European Commission is likely later this year. … READ MORE …

mCRPC patients with lower PSA levels respond better to sipuleucel-T

According to yet another re-analysis of data from the randomized Phase III trial that led to the original approval of sipuleucel-T (Provenge®), “the … treatment effect appeared greater with decreasing baseline PSA” in men with metastatic, castrate-resistant prostate cancer (mCRPC). … READ MORE …

Drug sequencing and combination therapy with newer prostate cancer therapies

There is an interesting report on the OncLive web site of a lecture by Dr. Robert Dreicer given just a few weeks ago and dealing with the sequential and combination use of new agents like abiraterone acetate, enzalutamide and others for the treatment of advanced and progressive forms of prostate cancer. … READ MORE …

New data on new and newer drugs at the GU Cancers meeting

A whole host of new data on drugs like sipuleucel-T, enzalutamide, abiraterone, and others was available in the poster sessions at the Genitourinary Cancers Ssympisum in Orlando today. … READ MORE …

Provenge + CT-011 + cyclophosphamide in treatment of mCRPC

The Georgia Health Sciences University in Augusta, GA, has initiated a new trial of sipuleucel-T (Provenge) in combination with cyclophosphamide and an investigational drug known as CT-011 for the treatment of chemotherapy-naive patients with progressive, metastatic, castrate-resistant prostate cancer (mCRPC). … READ MORE …

Appropriate sequencing of treatments among men with advanced prostate cancer

Whether a man is initially diagnosed with metastatic prostate cancer or progresses to have metastatic disease over time (after failure of standard first-line therapies), sooner or later they are all going to need — in consultation with their doctors — to decide on “the best” way to manage their progressive disease through sequential or concurrent use of a number of recently approved agents (always assuming that cost and access are not determining factors). … READ MORE …

Phase II trial of sipuleucel-T + indoximod in mCRPC

NewLink Genetics is to conduct an investigator-initiated, randomized, double-blind, placebo-controlled, Phase II trial of sipuleucel-T + indoximod (D-1MT/NLG8189) in the treatment of men with asymptomatic or minimally symptomatic, metastatic, castration-resistant prostate cancer (mCRPC). … READ MORE …

Expert commentary on new drugs for mCRPC

A videotaped expert commentary by Dr. Johann de Bono on the Medscape Oncology web site (with transcript) discusses four therapies (three now approved in the USA) that have recently demonstrated a survival benefit in the treatment of metastatic, castration-resistant prostate cancer.

CMS proposes Medicare coverage for Provenge

The Centers for Medicare and Medicaid Services (CMS) proposed yesterday that there is sufficient and adequate evidence to conclude that the use of autologous cellular immunotherapy treatment — sipuleucel-T (Provenge®) — improves health outcomes for Medicare beneficiaries … READ MORE …

Production ramp-up for Provenge on track

Dendreon’s production ramp-up for sipuleucel-T (Provenge®) is on track, the company says, with manufacturing expected to be up to full speed by year’s end. All three US-based manufacturing plants will be shipping by then, and treatment with Provenge should be available at hundreds of more locations, according to a Reuters report last week. … READ MORE …