International Agency for Research on Cancer

• Procaps Group, S.A. (NASDAQ: PROC) (“Procaps” or the “Company”), a leading integrated LatAm healthcare and pharmaceutical services company, announced today that it has entered into an agreement with BDR Pharmaceuticals International Pvt.
• Limited (“BDR Pharmaceuticals”) for 27 oncology molecules for Latin America, including 20 TKIs (Tirosyne Kinase Inhibitors).
• Under the agreement, Procaps is responsible for registration, branding, marketing and commercialization throughout Latin America.
• Procaps submitted an initial set of 8 molecules to the regulatory authority in Colombia and intends to later expand into other parts of Latin America.

• The World Health Organization declared on July 14, 2023, that the widely used synthetic sweetener aspartame could be a “possible” carcinogen, or cancer-causing agent, on the basis of “limited evidence for cancer in humans.” But the agency also concluded that the currently available data does not warrant a change of the acceptable daily intake of aspartame at this time.
• The Conversation asked chronic disease epidemiologist Paul D. Terry, public health scholar Jiangang Chen and nutrition expert Ling Zhao, all from the University of Tennessee, to put these seemingly contradictory findings into perspective based on the available scientific evidence.

1. Why is aspartame being classified as ‘possibly’ cancer-causing?

• Because it is approximately 200 times sweeter than table sugar, smaller amounts of aspartame are added to foods, and they contribute considerably fewer calories.
• NutraSweet and Equal are well-known brand names for aspartame sold in packages for individual use.
• The International Agency for Research on Cancer, an entity within the WHO, evaluated findings from both human and animal studies of aspartame and cancer.

2. What are the current guidelines for aspartame consumption?

• This amount of aspartame per day translates to approximately eight to 12 cans of soda, or approximately 60 packets of aspartame, for a person weighing 132 pounds (60 kilograms).
• For a child weighing 33 pounds (15 kg), it translates to between two to three cans of aspartame-sweetened soda per day, or approximately 15 packets of aspartame.

3. Does the WHO’s new stance change that recommendation?

• Independently of the expert panel on cancer, the food safety group also evaluated the available evidence and concluded that there was no “convincing evidence” from either animal or human studies that aspartame consumption causes adverse effects within the currently established daily limits.
• It is important to note that people with the rare inherited disorder called phenylketonuria, or PKU, should avoid or restrict aspartame intake.

4. How can two consensus groups reach different conclusions?

• It is not uncommon for scientific consensus groups to differ in how they classify risk based on the results of published studies, even if more than one of those consensus groups is affiliated with the same agency or parent organization.
• Whereas the WHO’s expert cancer group’s stance may appear to be more worrisome than that of the committee on food safety, in fact, the latter’s “no convincing evidence” is consistent with the cancer group’s “limited evidence” classification.

5. How does aspartame compare to other sweeteners?

• But, like aspartame, many of these sweeteners have been implicated in developing cancer.
• This list includes acesulfame potassium, or Ace-K – a synthetic calorie-free sugar substitute – as well as sugar alcohols and even simple sugar.

6. So what should consumers do?

• And, as noted by the Mayo Clinic, artificial sweeteners may play a beneficial role for some people who are seeking to manage their weight or control their sugar intake.
• One thing is clear: Scientific studies on aspartame consumption will continue, and it will be important for both consumers and the research community to continue weighing potential risks.

• They have recommended the acceptable daily intake be 0 to 40mg per kilo of body weight, as we currently have in Australia.
• The hazard rating means it’s an agent that is capable of causing cancer; a risk measures the likelihood it could cause cancer.

Firstly, what is aspartame?

• It’s used in a variety of products including carbonated drinks such as Coke Zero, Diet Coke, Pepsi Max and some home brand offerings.
• You can identify aspartame in drinks and foods by looking for additive number 951.
• In Australia the acceptable daily intake is 40mg per kilo of body weight per day, which is about 60 sachets.

What evidence have they used to come to this conclusion?

• They found there was some limited evidence in human studies linking aspartame and cancer (specifically liver cancer) and limited evidence from animal studies as well.
• They also considered the biological mechanism studies which showed how cancer may develop from the consumption of aspartame.
• Usually these are lab-based studies which show exactly how exposure to the agent may lead to a cancer.
• In this case they found there was limited evidence for how aspartame might cause cancer.

What does each grouping mean?

• There are 126 agents in this group, including tobacco smoking, alcohol, processed meat, radiation and ionising radiation.
• There are 95 agents in this group, including red meat, DDT insecticide and night shift work.
• There are now 323 agents in this group, including aloe vera (whole leaf extract), ginkgo biloba and lead.

So do I have to give up my diet soft drink habit?

• For a 70kg person you would need to consume about 14 cans (over 5 litres) of soft drink sweetened with aspartame a day to reach the acceptable daily intake.
• But we need to remember there may also be aspartame added in other foods consumed.
• But overall, from this evidence, drinking the occasional or even daily can of a diet drink is safe and probably not a cancer risk.

• The safety profile of datopotamab deruxtecan was consistent with previous clinical trials with no new safety signals identified.
• Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by AstraZeneca and Daiichi Sankyo.
• Patients without actionable genomic alterations were previously treated, concurrently or sequentially, with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
• AstraZeneca is also researching a potential diagnostic test to help identify patients most likely to benefit from treatment with datopotamab deruxtecan.