Pfizer’s elranatamab wins priority review from FDA for multiple myeloma

FDA has granted priority review to Pfizer’s (NYSE:PFE) bispecific antibody elranatamab for patients with relapsed or refractory multiple myeloma (RRMM).

Also known as PF-06863135, the immunotherapy won breakthrough therapy designation from the FDA for RRMM in November 2022.

The FDA has also accepted elranatamab’s Biologics License Application (BLA) while the European Medicines Agency (EMA) has accepted its Marketing Authorization Application (MAA).

Pfizer anticipates that it will commercialize elranatamab later this year.

The company estimates that elranatamab could generate $4 billion in peak sales. Pfizer anticipates that the drug candidate could capture between 40% and 80% of market share.

Elranatamab targets B-cell maturation antigen (BCMA) on the myeloma cell while binding to the CD3 protein present on the surface of T-cells. The drug candidate can thus unite myeloma cells and T-cells. That action activates the T-cells, ena…

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FDA grants breakthrough therapy designation to Pfizer’s elranatamab for multiple myeloma 

The investigational bispecfic antibody elranatamab has won breakthrough therapy designation from the FDA for relapsed or refractory multiple myeloma (RRMM).

Also known as PF-06863135, erlanatamab is a B-cell maturation antigen (BCMA)-targeted T-cell redirecting immunotherapy. BCMA is highly expressed on the surface of multiple myeloma (MM) cells. Elranatamab is also designed to target the CD3 receptor on the surface of T-cells to destroy myeloma cells.

Pfizer is developing elranatamab for subcutaneous use, which it believes could reduce adverse effects from the drug candidate such as cytokine release syndrome (CRS) while also offering improved convenience over IV infusions.

FDA previously granted fast track designation to the drug candidate to accelerate its rapid development and regulatory review.

To date, Pfizer has won twelve breakthrough therapy designations from FDA in oncology.

FDA’s decision to grant breakthrough therapy designation …

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10 promising oncology drug candidates

[3-D model of adagrasib molecule from PubChem]

The risk of cancer deaths has fallen steadily in recent years. Before the pandemic, the risk of death from cancer fell roughly 2% annually from 2015 to 2019. In the 1990s, the risk of cancer death fell approximately 1% each year, according to the American Cancer Society. In addition to improved screening and diagnosis, cancer survival rates have fallen as a result of therapeutic breakthroughs.

In this feature, we round up a variety of oncology drug candidates that may prove to be promising cancer therapeutics in the coming years.

1. Adagrasib

Adagrasib from Mirati Therapeutics is a KRASG12C inhibitor. In 2021, the drug candidate won Breakthrough Therapy Designation for patients with advanced non-small cell lung cancer (NSCLC) with the KRASG12C mutation. The KRAS protein inhibitor has been the subject of 14 trials to date, including a Phase 3 study focused on …

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Pfizer says employee stole confidential COVID-19 vaccine documents 

Pfizer (NYSE:PFE) accused a former employee Chun Xiao (Sherry) Li of uploading 12,000 documents from a company-issued laptop to a personal Google Drive account and various personal devices.

In a complaint filed in the U.S. District Court for the Southern District of California, Pfizer also accuses Li of misleading the company about what she did with the files she reportedly took, which included sensitive intellectual property.

The alleged stolen documents pertain to “numerous Pfizer vaccines, drugs, and other innovations,” including its COVID-19 vaccine and avelumab and elranatamab monoclonal antibodies.

The company jointly developed the COVID-19 vaccine with BioNTech. Pfizer jointly developed avelumab (Bavencio) with Merck KGaA, Darmstadt, Germany. The drug won FDA approval in 2020.

The bispecific monoclonal antibody elranatamab remains in the clinic.

The lawsuit notes that Pfizer…

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