Who Is the New FDA Commissioner? What Happened to Roche’s Immunotherapy Drug?



A New FDA Commissioner

The U.S. Senate Voted in Favor of Scott Gottlieb as the FDA Chief

– Dr. Gottlieb, a medical doctor graduated from Mount Sinai

– He held a high ranking position in the FDA during George W. Bush’s Presidency

– Senators who voted for based their choice on Mr. Gottlieb’s knowledge of the FDA and of the pharmaceutical industry; on his opinion regarding accelerating drug approval; encouraging the development of breakthrough drugs and encouraging flexibility in clinical trials.

– The voting against him was based on his ties to pharmaceutical companies, his opposition to risk evaluation and mitigation studies conducted by the FDA

– Dr. Gottlieb received a large support from the republicans, while most of the no votes came mainly from the democrats.

– It is said that Dr. Gottlieb will divest himself of holdings in the pharmaceutical industry and other businesses relate to the industry

Bottom line: We finally have a new commissioner for the FDA. We wish him good luck and wish that all the upcoming decisions he would be making be in favor of the patients first and foremost through real improvement of what has to be improved.


Failure of Roche’s Checkpoint inhibitor Tecentriq to Meet a Trial Primary Endpoint on Urothelial Cancer

Roche’s (RHHBY) checkpoint inhibitor Tecentriq® (atezolizumab) failed to meet the primary endpoint of Phase 3 IMvigor211 study.

Tecentriq is a monoclonal antibody targeting the checkpoint programmed death ligand 1 (PD-L1). The study was conducted on people with metastatic urothelial cancer (mUC) whose disease progressed during or after previous treatment with a platinum-based chemotherapy.

Commenting on the trial negative results, Sandra Horning, M.D., chief medical officer and Head of Global Product Development stated, “While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of people with advanced bladder cancer. We are committed to helping people with advanced bladder cancer and will discuss these data with health authorities.”

The data from IMvigor211 will be further examined in an effort to better understand the results.

Prohost Observations

It is obvious that many observers were surprised, including analysts and Roche’s itself as Sandra Horning, M.D. stated.

Confusion, no doubt about it followed the results, especially that Tecentriq has been granted accelerated approval based on positive results in the smaller IMvigor210 Phase 2 trial of the drug on the same cancer.  Indeed, the approval was granted based on tumor response rate and duration of response in Phase 2 IMvigor210 trial for people with locally advanced mUC who have disease progression during or following platinum-based chemo-therapy, or those whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery or after surgery.

Some analysts said that the new results put the approval in serious doubt while others suggested that the negative results might provoke the FDA into reviewing whether it should keep the drug on the market.

At Prohost, what we believe we should do in this respect is nothing but observing Tecentriq performances in the numerous clinical trials assessing its efficacy on several cancers. The drug is being assessed as monotherapy and in many combinations with other products on many malignancies.

Our opinion is that Tecentriq will survive these results and will help condemned people survive their advanced deadly cancers.

Our view stands on the fact that this is not the first immunotherapy checkpoint inhibitor to fail in a clinical trial. A similar situation has already occurred in the checkpoint inhibitor approved and marketed product Opdivo (novalumab). This immunotherapy, which belongs to BMY has failed to slow the progression of advanced lung cancer in a clinical trial compared to a conventional chemotherapy. Obdivo is still saving lives of cancer patients and still bringing in tremendous revenues  to BMY.

We remind that immunotherapy drugs are proving to reach their ultimate efficacy when combined with other appropriate targeted and non-targeted treatments.

We believe the news of not meeting a primary endpoint in one trial is not a death sentence to Roche’s immunotherapy PD-L1 inhibitor Tecentriq. The drug, which is in many trials on various cancers still have high odds of saving lives of desperate people, especially when used in  combi-nation therapy.

To read more details about the trials mentioned in this posting go to the Roche’s press release

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