Paclitaxel FDA Alerts

FDA Alerts Health Care Professionals and Oncology Clinical Investigators About Efficacy and Potential Safety Concerns with Atezolizumab in Combination with Paclitaxel for Treatment of Breast Cancer

September 8, 2020 -- FDA is alerting health care professionals, oncology clinical investigators, and patients that a clinical trial studying the use of atezolizumab (Tecentriq) and paclitaxel in patients with previously untreated inoperable locally advanced or metastatic triple negative breast cancer (mTNBC) showed the drug combination did not work to treat the disease.

Atezolizumab in combination with paclitaxel is not approved for use in breast cancer. However, atezolizumab in combination with paclitaxel protein-bound (Abraxane)—a different combination therapy—is currently approved for the treatment of adult patients with mTNBC whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥ 1% of the tumor area), as determined by an FDA-approved test. Continued approval of atezolizumab in combination with paclitaxel protein-bound may be contingent on proven benefit of the treatment in additional trials.

Health care professionals should not replace paclitaxel protein-bound (Abraxane) with paclitaxel in clinical practice.

The trial, IMpassion131, was a phase 3, multicenter, randomized, double-blind, placebo-controlled trial of atezolizumab in combination with paclitaxel compared with placebo and paclitaxel for patients with mTNBC.

In this clinical trial, treatment with atezolizumab and paclitaxel did not significantly reduce the risk of cancer progression and death compared with placebo and paclitaxel in the PD-L1-positive population. Additionally, interim overall survival results favored paclitaxel + placebo, over paclitaxel + atezolizumab in both the PD-L1-positive population and total population.

FDA will review the findings of IMpassion131 and will communicate new information regarding the IMpassion131 results and any potential changes to prescribing information. FDA is also evaluating the use of atezolizumab and paclitaxel in ongoing clinical trials for breast cancer and will recommend additional changes as appropriate.

Patients taking atezolizumab and paclitaxel for other approved uses should continue to take their medication as directed by their health care professional.

Patients should talk to their doctor if they have questions or concerns. Health care professionals and patients should report any adverse events or side effects related to the use of these products and other similar products to FDA’s MedWatch Adverse Event Reporting program.

• Complete and submit the report online; or
• Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Tecentriq Prescribing Information

Source: FDA

Hospira Injectable Drug Products: Recall - Visible Particulates from Defective Glass Vials

Including certain lots of the following products:

• carboplatin
• cytarabine
• paclitaxel
• methotrexate

[Posted 07/16/2012]

ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of certain injectable drug products, due to visible particles embedded in the glass located at the neck of the vial. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.

See the Press Release for a listing of affected product lot numbers and expiration dates.

BACKGROUND: These products were distributed nationwide to wholesalers and direct customers. Hospira completed an investigation and attributed the root cause to a supplier glass defect. Hospira is arranging for return/replacement etc. of all recalled products. Formal recall letters have been distributed within the US along with notification to safety organizations.

RECOMMENDATION: Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-628-0734 between the hours of 8am to 5pm EDT, Monday through Friday, to arrange for the return of the product.

[07/13/2012 - Press Release - Hospira, Inc]