FDA fully approves cervical cancer drug TIVDAK



New York and Copenhagen – Pfizer Inc. (NYSE: NYSE: ) and Genmab A/S (NASDAQ: NASDAQ: ) have received approval from the U.S. Food and Drug Administration (FDA) for TIVDAK® (tisotumab vedotin-tftv) for the treatment of relapsed or chronic Fully approved by disease sufferers.

The recognition follows positive results from the global Phase 3 study innovaTV 301, which met its primary endpoint by demonstrating an overall survival benefit in patients treated with TIVDAK compared with those treated with chemotherapy. The study showed that patients who received TIVDAK had a 30% lower risk of death and a median overall survival of 11.5 months, compared with 9.5 months for patients who received chemotherapy.

The FDA's decision to grant full approval is influenced by Priority Review designation, which is given to drugs that may provide significant therapeutic improvements over existing options. TIVDAK originally received accelerated approval in September 2021 based on tumor response rates in the Phase 2 innovaTV 204 trial.

The safety profile of TIVDAK was consistent with previous studies and showed no new safety concerns. However, the drug carries a boxed warning for ocular toxicity, and other warnings and precautions include peripheral neuropathy, bleeding, pneumonia, serious cutaneous adverse reactions, and embryo-fetal toxicity.

As the first antibody-drug conjugate to show significantly prolonged overall survival data in this patient population, TIVDAK represents a significant advance for women with advanced cervical cancer. The drug's approval is considered an important milestone in meeting the high unmet need for effective treatments for late-stage disease.

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Investment Professional Insights

TIVDAK's full FDA approval is an important milestone for Pfizer Inc. (NYSE: PFE), and the company's financial metrics and market performance also provide important insights for investors. Pfizer, a well-known company in the pharmaceutical industry, has been committed to shareholder returns, raising dividends for 13 consecutive years and maintaining dividend payments for 54 consecutive years, demonstrating good financial stability and investor confidence.this Investment Professional Tips Highlighting that Pfizer's net profit is expected to grow this year may be a sign that the company's strong pipeline and innovative treatments like TIVDAK are helping its financial health.

From a market perspective, Pfizer currently has a market capitalization of $144.85 billion and had an adjusted price-to-earnings (P/E) ratio of 19.79 for the trailing 12 months to the fourth quarter of 2023. 6.55%. The company's lower price volatility further reinforces its commitment to shareholder value, which may appeal to investors looking for stable returns during uncertain times.

For those wishing to delve deeper into Pfizer's financial and market performance, Investment Professional Tips It was revealed that analysts have mixed views on the company's prospects, with eight of them downgrading earnings for the period ahead. Nonetheless, analysts predict the company will remain profitable this year, bolstered by its trailing twelve-month profitability.Investors interested in exploring additional insights can find out more investment expert tip https://www.investing.com/pro/PFE, a total of 12 tips to guide their investment decisions.Also, use the coupon code PRONEWS24investors can enjoy an additional 10% discount on annual or bi-annual Pro and Pro+ subscriptions, gaining access to comprehensive analytics and data to inform their investment strategies.

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