On June 17, the FDA approved the first drug for the treatment of leukaemic acute myeloid leukemia (ALL), a rare but fatal blood disorder caused by a mutation of the BRCA1 gene.
The drug is currently being tested in a clinical trial and will likely be licensed by the end of this year.
The news comes as a blow to many in the cancer community, who have been urging the government to approve the drug.
“This is a devastating blow for patients,” said Daniela Knecht, senior vice-president of public affairs at the American Cancer Society, which had lobbied hard for approval of the drug, until the FDA rejected the petition.
“The FDA should be moving forward and making sure that people can get the drugs they need, and they’re not being treated unfairly.”
The FDA said in a statement that it is “confident that the drugs we are approving will improve quality of life for patients and protect the public health.”
The agency said that the approval is “designed to address the clinical challenges that have emerged with this devastating condition, and to support the development of new treatments that have not yet been approved by the FDA.”
But patients who have already undergone treatment with the drug may be left without an effective drug for several months.
This means that many will be forced to seek alternative therapies, such as a second-line therapy, or chemotherapy.
Many of the new treatments have also raised questions about the safety of the medication.
Last month, researchers at Johns Hopkins University in Baltimore announced that the first two patients treated with the new drug, a drug called AM-15, had died in the past year.
They said the drug did not improve survival rates, and their prognosis was also not good.
The FDA has been taking steps to address concerns about the drug and to reassure patients.
In May, the agency announced that it would issue guidelines to prevent patient harm when administering the drug for a month, in a bid to discourage drug companies from marketing the drug as a first-line treatment for ALL.
Last month, the federal government said that it had approved a second drug for ALL that is being tested at Johns Wayne State University, but that it was not yet ready for clinical trials.
The drug, called AMT-2, is a second option for treating patients who do not respond to other drugs.
It is being used in conjunction with a new chemotherapy option, called AZT, which also has been approved in the U.S. and Europe, and has been shown to be highly effective.
But there are concerns about whether AZT will improve survival in patients who would benefit from a second, or third, option.
The FDA has said that patients should not take AZT if they are experiencing symptoms of ALL, such to nausea, vomiting, and diarrhea.
The agency also said that treatment with AZT is not recommended for those with severe or advanced cancer.