Upside Foods, formerly Memphis Meats, will be able to bring its products to market once it has been inspected by the US Department of Agriculture (USDA). So far, only FDA has reviewed data from the company; however, the review is not technically an approval and applies only to Upside Foods’ products.

“We are thrilled at FDA’s announcement,” said David Kay, Upside Foods’ Director of Communications. “This historic step paves the way for our path to market.”

Meanwhile, according to FDA Commissioner Robert M. Califf and Susan Mayne, Director of the FDA’s Center for Food Safety and Applied Nutrition, the regulatory body is committed to supporting innovation in the food supply chain in the wake of a food revolution. This includes demand for alternatives to farmed meat, alongside awareness of the high greenhouse gas emissions of raising livestock.

The FDA remains ready to work with other firms to develop cultured animal cell food even as it sorts through a 2019 agreement with USDA, where USDA will oversee the processing and labeling of cell-cultured meat products.

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The Head of the US Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research, Peter Marks, has encouraged getting a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine for increased protection for high-risk persons. The FDA has already approved a second booster shot or fourth mRNA vaccine dose for American citizens aged 50 years old and above, to be taken at least 4 months after their previous COVID-19 vaccination.

However, the FDA authorisation is much more limited for those under 50 years old, and instead focuses only on those aged 12 and older who have undergone organ transplants, or have chronic medical conditions that leave them in highly immunocompromised states.

The FDA’s latest authorisation statement cites a lower age cut-off than expected following a recent application by biopharmaceutical company Pfizer looking only at boosters for those aged over 65 years – according to data, one in three people between the age of 50 and 65 suffer from pre-existing health conditions that are known to increase their risk of severe COVID-19.

Marks hopes to protect a large population of vulnerable individuals in that age bracket by authorising a fourth vaccine dose.

“Boosters are safe, and people over the age of 50 can now get an additional booster 4 months after their prior dose to increase their protection further,” said Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), who announced updated CDC recommendations regarding COVID-19 vaccines.

“This is especially important [for those] with underlying medical conditions that increase their risk for severe disease from COVID-19 as they are the most likely to benefit from receiving an additional booster dose at this time.”

Read: WHO Director-General “appalled” over global COVID-19 vaccine inequity

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This week, the US Food and Drug Administration (FDA) approved of a booster shot for the Pfizer-BioNTech (Pfizer) COVID-19 vaccine for at-risk individuals in the US. The FDA has amended the prior emergency use authorisation for Pfizer’s COVID-19 vaccine to now include a third booster dose to be given at least six months after the second dose; it will prioritise those over 65 and adults over 18 with health conditions putting them at high-risk of severe COVID-19.

The FDA’s booster decision includes a significant gray area in its third booster approval category – “individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19, including severe COVID-19.”

Acting FDA commissioner Janet Woodcock said this category could also include “health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others.”

Read: WHO Director-General “appalled” over global COVID-19 vaccine inequity

The Advisory Committee on Immunization Practices (ACIP) will decide what constitutes a “high-risk” individual and will offer their recommendations to the Centers for Disease Control and Prevention (CDC) at the soonest available date.

It is important to note that the FDA’s booster approval is limited to only the Pfizer COVID-19 vaccine, and offers no insight for Americans who previously received the Moderna or Johnson & Johnson vaccines. There is currently no advice or approval for booster shots for those vaccines, and there is no suggestion those who initially received the Pfizer vaccine can receive a booster of a different vaccine.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” added Woodcock. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

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by John Battersby

In the past the prognosis for patients with Neurotrophic tyrosine receptor kinase (NTRK) fusion cancer, was poor as the cancer did not respond well to most available therapies. But now a new class of drug, recently approved by the FDA and now available in more than 40 countries, is offering new hope to TRK fusion cancer patients with no other satisfactory alternative treatment options.

TRK fusion cancer occurs when an NTRK gene fuses with another unrelated gene, producing a chimeric TRK protein. The altered protein, or TRK fusion protein, becomes constitutively active or overexpressed, triggering a signalling cascade. These TRK fusion proteins are oncogenic drivers promoting cell growth and survival, leading to TRK fusion cancer (1). TRK fusion cancer is not limited to certain types of tissues and can occur in any part of the body. TRK fusion cancer occurs in various adult and paediatric solid tumours with varying frequency, including lung, thyroid, GI cancers (colon, cholangiocarcinoma, pancreatic and appendiceal), sarcoma, CNS cancers (glioma and glioblastoma), salivary gland cancers (secretory carcinoma of the salivary gland) and paediatric cancers (infantile fibrosarcoma and soft tissue sarcoma) where the frequency can be as high as 90% depending on the series investigated; making them almost pathognomonic of these disease states (2,3).

Related: Regular screenings can help save lives for men with colorectal cancer

Solid tumour cancers have traditionally been classified by location, for example: breast and lung cancer. But TRK fusion cancers are unusual in that they can grow almost anywhere in the body; the thyroid, soft tissue, lung, colon, and most dangerously the brain and central nervous system (CNS). Many cancers present in middle age or later but NTRK fusion cancers can strike at any age, and a high proportion of patients are children.

Which is why the latest update on the ongoing trials for larotrectinib is good news for CNS and paediatric patients with TRK fusion cancer.

The targeted therapy larotrectinib (marketed by Bayer under the brand name Vitrakvi) is a selective TRK inhibitor which targets TRK A, B and C. These are proteins which are involved in the development and maintenance of the nervous system. The rearranged, or fusion, state creates a chimeric oncoprotein which drives oncogenesis and this is the process larotrectinib is designed to shut down by binding to and inhibiting the TRK family of proteins. Because it targets the gene mutation that causes the cancer it can treat NTRK cancers wherever they occur in the body.

Larotrectinib was given preliminary approval by the FDA in 2019 in the tumour agnostic fashion for any cancer with an NTRK fusion, across any age including paediatric patients and infants. Rather than a single trial the regulatory data set the approval was based on was the pooled results of three trials of patients treated with larotrectinib. Those trial have been ongoing and the latest updates were presented by David S. Hong, M.D., (Professor of Investigational Cancer Therapeutics at the University of Texas MD Anderson Cancer Center) at the 2021 American Society of Clinical Oncology annual meeting.

The updates support and build on the generally positive conclusions of the original data; particular for the overall response rate (ORR), duration of response and progression-free survival (PFS). These outcomes compared favourably with, and indeed exceeded the outcomes of other contemporary, next generation, targeted TKI therapies for EGFR and ALT for instance (4).

Pull out: Report Highlights at a glance

The updates included waterfall plots, an ordered histogram depicting the best percentage change in tumour size with positive values representing increase in size of tumour and negative values representing shrinkage of tumour. The waterfall plots were broken down by cancer type giving a good indication of the likely response for any particular histology. Notably, the majority of patients, across histological types showed tumour shrinkage.

The swimmer plots, which show each study subject’s response to treatment over the course of the study, were also broken down by histology. Many of the swimmer plots showed very early response to treatment, often by the first radiologic follow up. In many cases the responses are still ongoing; for upwards of four years now for some of the paediatric patients.

The safety profile was consistent with that of the overall safety population previously reported and no new safety signals were identified. The majority of treatment-related adverse events (TRAEs) reported were primarily Grade 1 or 2, with 18% of patients reporting Grade 3 or 4 TRAEs. Two percent of patients discontinued larotrectinib due to TRAEs and no treatment-related deaths were reported. To summarise, this was a presentation of updated data, covering a larger cohort of patients ranging in age from one month to 82 years who had a NTRK fusion. The study found that larotrectinib was highly active, and achieved durable disease control with a very good safety profile (4).

The latest updated results have shown that the likelihood of response to larotrectinib is high, the likelihood of prolonged duration of response allowing the patient will be able to stay on the drug is high, and compared to other therapies the tolerability of this drug is very favourable.  All of which underline the importance of testing for NTRK fusion, it might be comparatively rare but if found it can be significant for the patient now that we have a targeted therapy.

References:

1. https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ntrk-gene-fusion

2. Okimoto RA, Bivona TG. Cancer Discov. 2016;6(1):14-16.

3. Vaishnavi A, et al. Cancer Discov. 2015;5(1):25-34.

4. Hong et al, (Long-term efficacy and safety of larotrectinib in an integrated data set of patients with TRK fusion cancer), Journal of Clinical Oncology, Volume 39, Issue 15_suppl    https://ascopubs.org/doi/abs/10.1200/JCO.2021.39.15_suppl.3108

In a stroke, damage to motor function on one side of the brain affects movement on the opposite side of a person’s body. Just this year, a novel device designed to help stroke patients recover wrist and hand function by overcoming this specific problem has been approved by the US Food and Drug Administration (FDA) – the IpsiHand system, the first brain-computer interface (BCI) device to ever receive FDA market approval.

The system is based on a discovery made by Eric Leuthardt and colleagues at the Washington University School of Medicine back in 2008: even if signals for body movement can be detected on the same side of the brain, these signals are still futile when the opposite side of the brain, which is actually responsible for executing the movement, is damaged. This specific brain activity was called ipsilateral brain signals.

The idea behind the IpsiHand BCI device was to find a way to detect those ipsilateral signals and use them to control an electronic hand brace. It was later demonstrated how patients using an experimental BCI device for 12 weeks, in the context of rehabilitation, significantly improved some degree of motor function by essentially retraining their brain to communicate with their hand.

“Generally, any motor impairments experienced by a patient six months after a stroke have been considered permanent,” said Leuthardt. “What we’ve found with this device is that many patients can get a meaningful improvement in recovery of upper extremity movement when we wouldn’t expect them to get any. That’s not really true for any of the current therapies for stroke aimed at restoring function after the initial recovery period.”

The IpsiHand device consists of two separate parts – a wireless exoskeleton that is positioned over the wrist, and a small headpiece that records brain activity using non-invasive electroencephalography (EEG) electrodes. The device wirelessly measure brain activity and, via a tablet, communicates with a hand brace allowing stroke patients to regain movement in a paralysed hand.

Although the IpsiHand is currently not available to patients, commercialisation and eventual clinical access should follow in late 2021, thanks to the FDA’s market authorisation. The approval was primarily based on clinical trial data showing significant motor function improvements when the device was used for 12 weeks, for around five times per week for at least 10 minutes each day.

“It is exciting to say that this is the first FDA-approved brain-computer interface for rehabilitation,” Leuthardt added. “People have been trying for a long time to convert BCI from an experimental technology into something that will truly help patients. With this, we’ve shown that BCI is finally ready for prime time. I sincerely hope there are many more such devices to follow.”

Read: Portable MRI pinpoints strokes that need surgical treatment

Thailand is underway to receive some 200,000 doses of Chinese-made Sinovac next month, according to news reports; Medical front liners, elderly people, and those in the high-risk groups are said to be prioritized.  The country has secured two million doses from Sinovac and will be arriving in batches of 800,000 and 1 million from March to April.  As of press time,  Sinovac roll-out still needs approval from the Food and Drug Administration (FDA). FDA is said to be awaiting documents from Sinovac for review of the vaccine’s safety and efficacy.

Surachoke Tangwiwat,  FDA’s Deputy Secretary-General has pledged to scrutinize the documents and  “scientific evidence” on the vaccines and will not expedite the approval process.  

Meanwhile, Prime Minister Prayut Chan-o-cha is also quoted as stating that half of the country’s population will get Covid-19 vaccines free of charge by this year.  

Read: Thailand secures 2 mn Sinovac Covid-19 vaccines; gets first 200K in Feb

The country is also gearing up the production of locally-made and affordable vaccines  from  Bangkok-based Siam Bioscience, which has  inked a partnership deal late last year with the British-Swedish pharmaceutical company, AstraZeneca to make 200 million doses/year of the COVID-19 vaccine, AZD1222.  Thai packaging solutions company, SCG has also joined in the partnership.