When Did Taxol Come Out? Tracing the Timeline of a Landmark Cancer Drug

October 6, 2025 •

3 min read

In December 1992, the U.S. Food and Drug Administration (FDA) first granted approval for the brand-name drug Taxol (paclitaxel) for the treatment of refractory ovarian cancer. The medication's journey from a rare tree bark to a life-saving chemotherapy, however, began decades earlier, marked by scientific breakthroughs, supply challenges, and significant milestones.

Quick Summary

The brand-name drug Taxol (paclitaxel) received its initial FDA approval in December 1992 for ovarian cancer treatment. This followed decades of research into the compound, which was first isolated from the Pacific yew tree bark in the 1960s.

Key Points

FDA Approved in 1992: The brand-name drug Taxol received its initial U.S. FDA approval in December 1992 for refractory ovarian cancer.
Discovery Began in the 1960s: The active compound, paclitaxel, was first isolated in 1967 from the bark of the Pacific yew tree, following a plant screening program initiated in 1962.
Sourcing was a Major Challenge: Early development was hampered by the difficulty and unsustainability of harvesting the bark from the slow-growing Pacific yew tree.
Semi-Synthesis Solved Supply Issues: The commercial production and availability of Taxol were enabled by a semi-synthetic method developed in the late 1980s, which utilized a renewable resource from the English yew.
Indications Expanded Over Time: After its initial approval, Taxol's use was expanded to treat advanced breast cancer (1994), non-small cell lung cancer (1999), and other cancers.
Unique Mechanism of Action: Taxol operates by stabilizing microtubules in cancer cells, disrupting cell division, which was a novel mechanism for chemotherapy at the time.

The Origins: Discovery from the Pacific Yew Tree

The story of Taxol begins with a large-scale plant screening program launched by the National Cancer Institute (NCI) in the 1960s, in collaboration with the U.S. Department of Agriculture (USDA). The goal was to test thousands of plant extracts for potential anti-cancer properties. It was in August 1962 that botanist Arthur Barclay collected bark from a Pacific yew tree (Taxus brevifolia) in Washington state. The extract from this bark showed promising cytotoxic activity against cancer cell cultures, but it was not until 1967 that researchers Mansukh Wani and Monroe Wall at the Research Triangle Institute isolated and identified the active compound, which they named taxol. The chemical structure was published in 1971.

Despite the promising early results, the development faced a major hurdle: the Pacific yew is a slow-growing tree, and obtaining enough bark to treat even one patient required killing several trees. This made commercial production from natural sources unsustainable and environmentally damaging. This supply issue, along with technical challenges, meant the drug remained in early-stage development for years.

The Commercialization and FDA Approval

The turning point came with the development of a semi-synthetic manufacturing process and a partnership with a pharmaceutical company. In 1989, facing intense demand for the drug, the NCI and Bristol-Myers Squibb (BMS) entered a Cooperative Research and Development Agreement (CRADA) to accelerate commercial production. Crucially, a method was developed by Robert Holton at Florida State University to create paclitaxel from a more abundant compound found in the needles of a European yew, a renewable resource. BMS licensed this technology, paving the way for larger-scale manufacturing.

The FDA's expedited review process for life-saving drugs helped bring Taxol to market quickly.

Key FDA Approval Milestones for Taxol (Paclitaxel):

December 1992: Initial FDA approval for the treatment of refractory ovarian cancer.
1994: Approval for the treatment of advanced breast cancer.
1999: Approval for non-small cell lung cancer.
Later Approvals: Expanded indications to include AIDS-related Kaposi's sarcoma and other cancers.

Taxol and Its Formulations: A Comparison

The original Taxol formulation relied on a solvent system called Cremophor EL to make the drug soluble for intravenous injection. This solvent was associated with severe allergic reactions, requiring pre-medication. Subsequent advancements led to alternative formulations designed to mitigate these side effects and improve delivery.


Feature	Taxol (Original Formulation)	Abraxane (Albumin-Bound Paclitaxel)
Formulation	Dissolved in a castor oil-based solvent (Cremophor EL)	Bound to albumin nanoparticles for targeted delivery
Allergic Reactions	Higher risk, requires pre-medication	Lower risk, no pre-medication needed
Side Effects	Common side effects include bone marrow suppression, peripheral neuropathy, hair loss, and infusion reactions	Similar side effect profile, but some toxicities may differ due to formulation
FDA Approval	1992 (Ovarian Cancer)	2005 (Breast Cancer)

Therapeutic Impact and Mechanism of Action

Taxol revolutionized cancer treatment with its unique mechanism of action. As a taxane drug, it works by stabilizing the microtubules within cancer cells. Microtubules are essential for cell division. By preventing their breakdown, Taxol disrupts the cell's ability to complete mitosis, ultimately leading to cell death. This novel approach made it effective against various cancers, even those resistant to other forms of chemotherapy.

Over its history, Taxol has been used to treat a wide array of malignancies, including:

Breast cancer
Ovarian cancer
Non-small cell lung cancer
AIDS-related Kaposi's sarcoma
Pancreatic cancer (using special formulations like Abraxane)
Bladder, prostate, and esophageal cancers

A Legacy of Innovation

Since its first approval, Taxol has provided hope and extended life for countless cancer patients worldwide. Its success also highlighted the importance of natural product drug discovery and spurred innovation in pharmaceutical manufacturing to overcome resource limitations. The journey of Taxol from a single tree bark sample to a global blockbuster drug underscores the perseverance required in medical research and the complex partnerships involved in bringing new therapies to market.

For more detailed scientific information, readers can refer to the National Cancer Institute's website.

Conclusion

To answer the question, when did Taxol come out? the official market debut for the brand-name drug was in December 1992, with its initial FDA approval for ovarian cancer. However, this date marks the culmination of a decades-long saga that began with its discovery in 1962. The story of Taxol's development, from sourcing challenges and semi-synthetic breakthroughs to its widespread clinical use, represents a significant chapter in modern pharmacology and oncology, solidifying its place as a transformative and life-saving medication.

Frequently Asked Questions

The active compound in Taxol, paclitaxel, was first isolated by researchers Mansukh Wani and Monroe Wall in 1967 at the Research Triangle Institute, five years after a plant sample from the Pacific yew tree was collected.

The pharmaceutical company Bristol-Myers Squibb (BMS) commercialized Taxol under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) in the early 1990s.

The first FDA approval for Taxol was in December 1992 for the treatment of refractory ovarian cancer.

The lengthy development process was primarily due to the severe supply constraints and environmental concerns associated with harvesting bark from the Pacific yew tree, which killed the tree. It took years to develop a sustainable semi-synthetic production method.

Taxol is the brand name for the generic chemotherapy drug paclitaxel, commercialized by Bristol-Myers Squibb. While paclitaxel is the active compound, Taxol refers to the specific formulation sold under that brand name.

In addition to ovarian cancer, the FDA later approved Taxol for the treatment of advanced breast cancer, non-small cell lung cancer, and AIDS-related Kaposi's sarcoma.

The original Taxol formulation used a castor oil-based solvent (Cremophor EL) that caused severe allergic reactions. This prompted the development of newer formulations, like Abraxane (albumin-bound paclitaxel), to avoid these solvent-related issues.