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Roche's Subcutaneous Tecentriq Approved; Gilead's HIV Shot Shows Promise

• The FDA approved Roche's Tecentriq Hybreza, the first checkpoint inhibitor available as a subcutaneous injection, offering a faster administration time of about seven minutes. • Gilead's twice-yearly lenacapavir HIV shot reduced infection risk by 96% in a Phase 3 trial, leading to halted trial and plans for regulatory filings and a potential 2025 launch. • Sanofi has secured rights to an experimental radiopharmaceutical drug for a rare form of cancer, marking its entry into the fast-growing field of radiopharmaceuticals. • Eli Lilly is investing $1 billion to expand its manufacturing site in Ireland to produce the active ingredient for its Alzheimer's drug Kisunla and other medicines.

Roche's cancer immunotherapy Tecentriq has received FDA approval for a subcutaneous injection formulation, marketed as Tecentriq Hybreza. This approval marks a significant advancement, making it the first checkpoint inhibitor available via subcutaneous administration. The new formulation offers a substantially reduced administration time of approximately seven minutes, compared to the 30 to 60 minutes required for intravenous infusions of the original Tecentriq.

Tecentriq Hybreza: A Faster Option for Cancer Immunotherapy

Tecentriq Hybreza is approved for all indications of the original Tecentriq, encompassing various cancer types, including tumors of the skin, lung, and liver. This subcutaneous option provides a more convenient and potentially less burdensome treatment experience for patients. Roche's achievement puts them ahead of competitors like Merck & Co. and Bristol Myers Squibb in the race to offer subcutaneous checkpoint inhibitors.

Gilead's Lenacapavir Shows Strong HIV Prevention Results

Gilead Sciences announced positive results from a Phase 3 trial of its twice-yearly HIV shot, lenacapavir. The trial demonstrated a 96% reduction in HIV infection risk compared to background disease incidence among nearly 2,200 cisgender men and gender-diverse individuals. Following these compelling results and the success of a previous late-stage study in women, Gilead has decided to stop the blinded portion of the trial.
"Gilead will work urgently to bring the shot, called lenacapavir, to patients. The company expects to begin regulatory filings this year, with an initial launch possible in 2025."

Sanofi Enters Radiopharmaceutical Field

Sanofi is expanding its oncology portfolio through a licensing and collaboration agreement with RadioMedix and Orano Med, securing rights to an experimental radiopharmaceutical drug targeting a rare form of cancer originating from neuroendocrine cells. Sanofi will pay 100 million euros upfront for the rights to the drug. This move signifies Sanofi's entry into the rapidly evolving field of radiopharmaceuticals. While the drug targets the same cancer as Novartis' Lutathera, it utilizes an alpha particle-emitting lead isotope instead of beta-emitting lutetium.

Eli Lilly Expands Manufacturing for Alzheimer's Drug

Eli Lilly is investing $1 billion to expand its manufacturing facility in Limerick, Ireland. This expansion will support the production of the active pharmaceutical ingredient for Kisunla, Lilly's recently approved Alzheimer's disease medicine, as well as other drugs. Construction began in 2022, and the company anticipates that the site will begin producing drug ingredients in 2026. This investment is part of a larger manufacturing expansion campaign driven by Lilly's success in Alzheimer's and obesity treatments.
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Reference News

[1]
Subcutaneous Tecentriq gets FDA OK; Gilead shot succeeds in second HIV trial
biopharmadive.com · Sep 13, 2024

Roche's subcutaneous Tecentriq approved for cancer treatment; Gilead's twice-yearly HIV shot reduces infection risk by 9...

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