Transforming Shots Into Pills; ‘Tip of the Iceberg’ for TILs? Food Additives Warning

A California startup has the lofty goal of transforming blockbuster injectable and infusional drugs into pills. (Endpoints News)

Johnson & Johnson announced FDA approval of a less frequent dosing regimen for teclistamab (Tecvayli) to treat relapsed/refractory multiple myeloma.

Biosimilars to the blockbuster immunotherapy pembrolizumab (Keytruda) are heading into clinical trials. (Endpoints News)

The FDA’s first-ever approval of a tumor-infiltrating lymphocyte (TIL) therapy — lifileucel (Amtagvi) for melanoma — “is the tip of the iceberg” for what the drug class can bring to cancer treatment. (Axios)

Lifileucel is projected to become a major player in the therapeutic field for melanoma. (GlobalData)

The FDA expanded lung cancer indications for osimertinib (Tagrisso) to include use in combination with platinum-containing chemotherapy for locally advanced/metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutations.

Oncopeptides announced that the FDA has concluded that grounds are sufficient to withdraw melphalan flufenamide (Pepaxto) from the U.S. market, a decision Oncopeptides had appealed.

The Pharmaceutical Research and Manufacturers Association introduced Daniel O’Day of Gilead Sciences as the organization’s new chairman of the board of directors.

Bavarian Nordic terminated a cancer vaccine study and announced plans to discontinue cancer research in favor of developing therapies for infectious diseases. (Biopharma Dive)

More evidence that additives commonly used in ultraprocessed foods may increase the risk of certain types of cancer. (Newsweek)

How will the FDA’s recent emphasis on overall survival as a primary endpoint for drug approvals affect development of cancer drugs? (BioSpace)

Prophylactic oral vancomycin reduced the risk of Clostridium difficile infection in stem-cell transplant recipients but at the cost of an increased risk of gram-negative bacteremia. (Fox Chase Cancer Center)

Addition of a novel immunotherapy based on DNA plasmid technology more than doubled progression-free survival compared with chemotherapy alone in platinum-resistant ovarian cancer. (Frontiers in Oncology)

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