Genentech Gets FDA Priority Review Designation for Combination Treatment of Triple-Negative Breast Cancer

Edward Kim  |

~ Tecentriq-Abraxane combination would be the first cancer immunotherapy for PD-L1-positive, metastatic triple-negative breast cancer ~

According to the American Cancer Society, over 266,000 women will be diagnosed with breast cancer in 2018, while nearly 41,000 women will die from the disease this year. Excluding certain types of skin cancer, breast cancer remains the most common cancer among women. The majority of breast cancer patients have cancer cells with certain receptors—estrogen receptor, progesterone receptor or human epidermal growth factor receptor 2 (HER2)—that can be targeted with hormone therapy such as tamoxifen (Nolvadex) and HER2 therapy such as trastuzumab (Herceptin). In patients with triple-negative breast cancer, however, the cancer cells lack all of these receptors and are therefore not treatable with these drugs. Triple-negative breast cancer accounts for about 15% of breast cancer incidence among white women and 35% among black women. Its aggressiveness is frequently exacerbated by advanced disease stage and high-grade tumors at diagnosis, and it has a higher risk of recurrence and poor five-year survival rates relative to other breast cancers.

Genentech, part of the Roche Group  (RHHBY), announced today that the it has received Priority Review designation from the FDA for the supplemental Biologics License Application (sBLA) for the combination of Tecentriq (atezolizumab) plus nanoparticle albumin-bound paclitaxel (nab-paclitaxel) for the initial treatment of unresectable locally advanced or metastatic triple-negative breast cancer in people whose disease expresses the PD-L1 protein. If approved, this combination would be the first cancer immunotherapy regimen for the treatment of PD-L1-positive, metastatic triple-negative breast cancer.


Source: Dana-Farber Cancer Institute

The FDA's Priority Review designation puts a six-month time frame on its drug application review process, as compared to 10 months for a Standard Review. The FDA gives Priority Review to those applications for drugs that would provide "significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications." The FDA is expected to make a decision on approval by March 12, 2019.

Blocking the PD-L1 (programmed death-ligand 1) protein is a recognized approach to fighting cancer, as PD-L1 works to inactivate T cells which are critical to the body's immune response. Tecentriq is a PD-L1 inhibitor for which Genentech currently has FDA approval in the treatment of urothelial carcinoma and non-small cell lung cancer (NSCLC). Nab-paclitaxel, marketed as Abraxane by Celgene  (CELG), is approved for advanced breast cancer in people who have already received certain other medicines for their cancer, and in combination therapy for advanced non-small cell lung cancer (with carboplatin) in people who cannot be treated with surgery or radiation and for advanced pancreatic cancer (with gemcitabine) as the first medicine for advanced pancreatic cancer.

Tecentriq in combination with nab-paclitaxel has the potential to meaningfully advance treatment for people with PD-L1-positive, metastatic triple-negative breast cancer. People need more options for this type of breast cancer, which is particularly difficult to treat. We are working closely with the FDA to bring this Tecentriq combination to people with PD-L1-positive, metastatic triple-negative breast cancer as soon as possible.

- Sandra Horning, MD, Chief Medical Officer and head of Global Product Development, Genentech.

The data from the relevant Phase III study, which was presented at the European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine in October 2018, showed that the combination of Tecentriq plus nab-paclitaxel as an initial (first-line) treatment for unresectable locally advanced or metastatic triple-negative breast cancer significantly reduced the risk of disease worsening or death (progression-free survival; PFS) compared to nab-paclitaxel. Median PFS was 7.2 months with the combination therapy vs 5.5 months with nab-paclitaxel alone all patients. In the PD-L1-positive group, median PFS was 7.5 months with the combination therapy vs 5.0 months with nab-paclitaxel alone.

Genentech currently has seven ongoing Phase III studies investigating Tecentriq in triple-negative breast cancer, including early and advanced stages of the disease. We salute the FDA for implementing its Priority Review program effectively, along with its many other processes in place to expedite potential cures for the most serious diseases.


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Companies

Symbol Name Price Change % Volume
CELG Celgene Corporation 69.26 1.06 1.55 2,481,852 Trade
RHHBY Roche Holding Ltd ADR (Sponsored) 31.18 0.09 0.29 244,882

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