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Study finds many cancer drugs still lack evidence years after receiving accelerated FDA approval

In a recent study, researchers discovered that many cancer drugs granted accelerated approval by the U.S. Food and Drug Administration (FDA) do not provide significant benefits to patients within five years of approval. The accelerated approval program was established in 1992 to expedite access to promising drugs, particularly for serious diseases like cancer.

Dr. Ezekiel Emanuel, a cancer specialist and bioethicist at the University of Pennsylvania, expressed concern about the lack of definitive answers regarding the efficacy of these drugs five years after approval. He highlighted that thousands of patients are receiving these drugs without knowing if they actually work.

The study focused on cancer drugs granted accelerated approval between 2013 and 2017. Out of 46 drugs studied, only 43% demonstrated a clinical benefit in confirmatory trials, yet 63% were ultimately granted regular approval by the FDA. This discrepancy raises questions about the thoroughness of testing and the reliability of accelerated approvals.

While the program allows patients to access drugs earlier, there is a tradeoff in terms of uncertainty and potential lack of effectiveness. Patients may not be fully informed about the limitations of drugs with accelerated approval, leading to potential misconceptions about their benefits.

Dr. Jennifer Litton of MD Anderson Cancer Center emphasized the importance of transparent communication between doctors and patients regarding the evidence supporting accelerated approval drugs. It is crucial for healthcare providers to manage expectations and provide accurate information about the potential benefits of these medications.

Recent updates to the accelerated approval program aim to enhance oversight and facilitate the withdrawal of drugs that fail to meet efficacy standards. The FDA now has greater authority to revoke approvals and can require confirmatory trials to be initiated prior to granting preliminary approval, expediting the verification process.

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In conclusion, the study sheds light on the challenges and uncertainties surrounding accelerated approval of cancer drugs. It underscores the need for improved transparency, thorough testing, and clear communication to ensure that patients receive effective treatments. With ongoing advancements in regulatory oversight, the hope is that future approvals will be based on solid evidence of clinical benefit, ultimately benefiting patients with cancer.

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Is now the right time to invest in gold as prices have cooled?

Now may be the time to buy gold following a recent lull in its price.

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The price of gold has climbed to record highs recently and has remained strong through much of April. And, that growth continued until the precious metal traded at around $2,390 per ounce on April 19, 2024. But since, growth in the price of the precious metal has cooled, with gold’s price now hovering around $2,300 per ounce.

This lull in gold’s price may represent an investment opportunity.

In general, investing is centered around buying assets when prices are low and selling them when prices are high – generating a profit on the difference between the two. So, considering the declines in gold’s price over the past few days, now may be the time to make your investment. But is buying gold during this lull in prices really a good idea?

Compare your gold investment options among leading brokers now.

Gold prices have cooled. Should you buy in now?

With gold’s price down from recent highs, you may be wondering if now is the right time to buy in. There are several reasons the dip in gold’s price may represent an opportunity to buy. Here are some of the biggest:

Prices may rise again

If looking at a gold price chart shows anything for certain, it shows that changes in the overall growth of the medal come in fits and spurts. Periods of price growth are typically followed by periods of declines and vice versa.

But with inflation rising in recent months – and with gold’s reputation as a safe-haven asset that can hedge against inflation – it only makes sense that the price of the precious metal will eventually start to head up again in the future. While attempting to time that directional change may be tricky, buying the precious metal while the price is down gives you the opportunity to take advantage of any upward movement that may be ahead.

Add gold to your portfolio now before prices have a chance to rise.

You may be able to make a quick profit

Gold isn’t known as an asset in which you can earn a quick return, but in today’s market, that may be the case. Don’t forget that in January, gold was trading at just $2,000 per ounce. And, by mid-April, the commodity’s price had climbed to around $2,400 per ounce. That’s about 20% growth in a matter of months, much of which happened since March 1 – an impressive climb for any investment asset.

Perhaps more importantly, gold’s price growth through the beginning of 2024 shows that the commodity doesn’t have to be a buy and hold style investment that you keep in a safety deposit box or precious metal depository for years to come. There’s also the possibility that the commodity’s price could climb further ahead, making it a compelling way to potentially generate a quick profit.

There are other benefits of investing in gold

There are other benefits of investing in gold that have little to do with the price growth seen thus far in 2024 – or the lull in prices seen over the past couple of days. Those benefits include:

Inflation protection: Gold has long been considered an inflation hedge, and for good reason. When inflation drives the prices of consumer goods and services up – and the value of the dollar down – gold’s price tends to rise. So, it could be used to maintain the value of your portfolio during inflationary economic conditions. That’s important in today’s economic environment as stubborn inflation continues to weigh on the value of the dollar.
Portfolio diversification: Gold’s price doesn’t always move in the same pattern that bonds or stocks do. So, mixing a reasonable amount of gold into your portfolio (up to 10% of your portfolio assets) as a diversifier could protect you from losses should one or more of your traditional portfolio assets fall in value. “If you have less than 5% – 10% of your net worth in commodities & FX (forex), you should absolutely consider adding exposure to gold and other precious metals,” says Vijay Marolia, money manager and managing partner at the wealth management firm, Regal Point Capital.

The bottom line

Gold’s price has fallen from recent highs – which may represent an opportunity to tap into growth ahead. However, gold isn’t simply a “buy while it’s low and sell while it’s a high” kind of investment opportunity. The commodity can also protect your portfolio from the stubborn inflation we’ve seen thus far in 2024 while acting as a diversification tool that could increase your risk-adjusted portfolio returns. So, consider adding gold to your portfolio today while it has the potential to grow in value.

Joshua Rodriguez

Joshua Rodriguez is a personal finance and investing writer with a passion for his craft. When he’s not working, he enjoys time with his wife, two kids, two dogs and two ducks.