Tag: cancer

FDA delays decision on Bristol Myers cancer therapy due to COVID-19 travel curbs

(Reuters) – Bristol Myers Squibb said on Monday the U.S. health regulator has deferred a decision on an experimental blood cancer therapy that it acquired in the $74 billion buyout of Celgene due to coronavirus-related travel restrictions.



a blue sign in front of a building: Signage is seen outside of FDA headquarters in White Oak, Maryland


© Reuters/ANDREW KELLY
Signage is seen outside of FDA headquarters in White Oak, Maryland

The U.S. Food and Drug Administration (FDA) was unable to inspect a third-party manufacturing facility in Texas, a step required before the approval of the drug liso-cel, the company said.

The health regulator warned earlier this year its level of timely reviews and approvals of marketing applications could be impacted by the COVID-19 crisis, which forced the FDA in October to also delay a decision on a Spectrum Pharmaceuticals drug.

Video: Therapeutic Goods Administration expedites approvals for coronavirus vaccine (ABC NEWS)

Therapeutic Goods Administration expedites approvals for coronavirus vaccine

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Bristol Myers said on Monday the agency had deferred its application until the inspection can be completed. The FDA was earlier expected to complete the review process by Nov. 16.

The agency’s approval of liso-cel by Dec. 31, 2020, is one of the remaining milestones required for Celgene investors to receive a conditional payment of $9 per share.

(Reporting by Mrinalika Roy in Bengaluru; Editing by Aditya Soni)

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Melbourne cancer patient rejected from Queensland hotel quarantine exemption is angry at NRL players

A terminal cancer patient is outraged she was rejected for a hotel quarantine exemption while celebrities and athletes are given special treatment.

Regional Victorian woman Bree McQuilty wants to visit her family in Brisbane for Christmas before she dies and quarantine at their home rather than a hotel. 

Ms McQuilty’s doctors argue she will be at greater risk in a hotel due to her weakened immune system and have provided supporting letters for her – but she has been rejected from hotel quarantine three times. 

Regional Victorian woman Bree McQuilty (right) and her mother Sandie Graham, who lives in Brisbane. Ms McQuilty, who has terminal cancer, wants to quarantine at her family home in Brisbane but her hotel quarantine exemption has been rejected three times

Regional Victorian woman Bree McQuilty (right) and her mother Sandie Graham, who lives in Brisbane. Ms McQuilty, who has terminal cancer, wants to quarantine at her family home in Brisbane but her hotel quarantine exemption has been rejected three times

Ms McQuilty’s mother Sandie Graham said it was unfair that her daughter was not given an exemption while celebrities were. 

‘Where is the fairness? You read about celebrities and they can have 30,000 people at a football match, but a person with terminal cancer who even has letters from her doctor can’t get a look in,’ Ms Graham told The Courier Mail. 

‘This may be Bree’s last Christmas so we’re just hoping that they will relax the restrictions by then.’

There are about 3,700 people in forced hotel quarantine in Queensland, which costs $2,800 for an adult, $3,710 for a couple or $4,620 for a family of four.  

Meanwhile, Melbourne Storm coach Craig Bellamy is living it up in a beachfront apartment on the Sunshine Coast. 

Melbourne Storm's Cameron Smith prior to the NRL Grand Final. The Storm are staying in a Sunshine Coast 'bubble' after winning the Grand Final in Sydney last month

Buddy Franklin and other AFL players at a 'quarantine hub' during the season.

Melbourne Storm’s Cameron Smith (left) prior to the NRL Grand Final. The Storm are staying in a Sunshine Coast ‘bubble’ after winning the Grand Final in Sydney last month. Similarly, AFL players (right), their significant others and children formed ‘AFL hubs’ at various resorts and golf courses in Queensland during their season

A 'vague' email Ms McQuilty received from Queensland Health before being rejected from a hotel quarantine exemption

A ‘vague’ email Ms McQuilty received from Queensland Health before being rejected from a hotel quarantine exemption

Bellamy and his players were all granted exemptions to quarantine and are staying in a Sunshine Coast ‘bubble’ after winning the Grand Final in Sydney last month.

They are required to quarantine for 14 days in private homes or ‘approved government accommodation’.

Similarly, AFL players, their significant others and children formed ‘AFL hubs’ at various resorts and golf courses in Queensland during their season. 

Actor Tom Hanks was also granted special treatment for his hotel quarantine, staying at a Broadbeach resort rather than a quarantine hotel in September.    

More recently, Masked Singer judge Dannii Minogue was completely exempt from hotel quarantine after arriving in Queensland from the US.  

Despite the clear double standard, Ms McQuilty said she ‘doesn’t care’ about what Dannii Minogue and other celebrities are doing. 

Masked Singer judge Dannii Minogue (pictured) was completely exempted from hotel quarantine after arriving in Queensland from the US. Actor Tom Hanks was also granted special treatment for his hotel quarantine, staying at a Broadbeach resort rather than a civilian-filled hotel in September

Masked Singer judge Dannii Minogue (pictured) was completely exempted from hotel quarantine after arriving in Queensland from the US. Actor Tom Hanks was also granted special treatment for his hotel quarantine, staying at a Broadbeach resort rather than a civilian-filled hotel in September

‘There are far more logical points in my set

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The family of a Freeport cancer survivor is grateful for a donate

The family of a Freeport cancer survivor is grateful for a donated vacation and a break from the disease.

FREEPORT, Maine — October is National Breast Cancer Awareness Month, reminding women that self-exams and mammograms are key to catching the disease early. 

More than 300,000 new cases of breast cancer are diagnosed each year and recovering from cancer battles happens in different ways. A donated vacation helped put a Freeport family on the path to healing. 

“I had an MRI, the lump was very large, almost 8 centimeters,” Gina LeDuc-Kuntz said.

The Freeport resident was diagnosed with an aggressive breast cancer, evasive papillary carcinoma, after finding a lump in her left breast nearly two years ago.

The mother of six underwent six months of chemotherapy, a radical mastectomy, and 25 rounds of radiation because the disease was so advanced. Her three younger children, ages 10 to 15, were still at home.

“There was no focus on them. They had enormous needs. Their mother was going through cancer treatment. It was terrible,” Gina recalled. 

When Gina finally finished with her grueling regime,e another challenge came up.

“Going through this extreme treatment plan right into COVID, we have been kind of isolating for two years now,” Gina said.  

This summer, Gina was notified that she and her family were the recipients of a free getaway.

The Little Pink Houses of Hope provides cancer patients, survivors, and their families retreat at vacation destinations across the country. Gina and her family applied and were accepted to spend a week in a donated condo at Orange Beach, Alabama. Though a little concerned about traveling during the pandemic, Gina and her family desperately needed to reconnect.

While in Orange Beach, Gina and her family visited state parks, historical sites, fished, and frolicked on the beach. 

Everyone followed precautions against COVID as they bonded as a family. They also spent time getting to know other survivors of breast cancer and their families. Sharing their stories also had a common theme.  

‘All of us women all thinking not ‘how am I going to get through these treatments’, but ‘I can’t die because I have my family,'” Gina said. 

A new focus Gina says is helping her move forward towards healing.

For information on the Little Pink Houses of Hope, a non-profit organization, click the highlighted link.

For information on prevention, diagnosis, and treatment of breast cancer from the American Cancer Society, click here.


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