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Tokyo: Daiichi Sankyo‘s DATROWAY (datopotamab deruxtecan) has been approved in Japan for the treatment of adult patients with hormone receptor (HR) positive, HER2
negative (IHC 0, IHC 1+ or IHC 2+/ISH-) unresectable or recurrent breast cancer after prior chemotherapy.
In Japan, breast cancer is the most common cancer in women.1 Approximately 92,000 cases of breast cancer
were diagnosed in Japan in 2022, with approximately 17,600 deaths. It is estimated that 70% of diagnosed
cases are considered what has been historically called HR positive, HER2 negative breast cancer (measured
as HER2 score of IHC 0, IHC 1+ or IHC 2+/ISH-).
DATROWAY is a TROP-2 directed medicine to be approved in Japan for HR positive, HER2
negative breast cancer and is the second DXd antibody drug conjugate (ADC) approved based on Daiichi
Sankyo’s DXd ADC Technology.
The approval of DATROWAY by the Japan Ministry of Health, Labour and Welfare (MHLW) is based on
results from the TROPION-Breast01 phase 3 trial. In this trial, DATROWAY significantly reduced the risk
of disease progression or death by 37% compared to investigator’s choice of chemotherapy (hazard ratio
[HR]=0.63, 95% confidence interval [CI]: 0.52-0.76; p<0.0001) in patients with HR positive, HER2 negative
metastatic breast cancer as assessed by blinded independent central review (BICR). Median progression-free
survival (PFS) was 6.9 months in patients treated with DATROWAY compared to 4.9 months in those
treated with chemotherapy.
“This first global approval of DATROWAY provides patients in Japan with metastatic HR positive, HER2
negative breast cancer a new alternative to conventional chemotherapy, which is often associated with poor
response rates,” said Wataru Takasaki, PhD, Senior Advisor, Daiichi Sankyo. “DATROWAY also is the
second DXd antibody drug conjugate approved in Japan based on technology invented by Daiichi Sankyo,
emphasizing our commitment to creating new, innovative standards of care for patients with cancer.”
In TROPION-Breast01, adverse reactions occurred in 93.6% (337/360 patients) of the 360 patients
(including 31 Japanese patients) in the DATROWAY (6 mg/kg) arm.
In
Japanese patients, interstitial lung disease (ILD) occurred in 6.5% of patients treated with DATROWAY.
DATROWAY is approved in Japan with a Warning for ILD. As cases of ILD, including fatal cases, have
occurred in DATROWAY-treated patients.
“DATROWAY is to be used in close collaboration with a
respiratory disease expert. Patients should be closely observed during therapy by monitoring for early signs
or symptoms of ILD (such as dyspnea, cough or fever) and performing periodical percutaneous oxygen
saturation (SpO2) tests, chest X-ray scans and chest CT scans. If abnormalities are observed, discontinue
administration of DATROWAY and take appropriate measures, such as corticosteroid administration. Prior
to initiation of DATROWAY therapy, a chest CT scan should be performed and medical history taken to
confirm the absence of any comorbidity or history of ILD with the patient and carefully consider the
eligibility of the patient for DATROWAY therapy,” the release stated.
Additional regulatory submissions for DATROWAY in breast cancer are under review in the EU, China,
U.S. and other regions.
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Mumbai: Homeopathic practitioners are eligible to prescribe allopathic medicines if they have completed a certificate course in modern pharmacology, the Maharashtra Food and Drug Administration has recently clarified.
Issuing a directive in this regard to the chemist retailers and wholesalers in the State, Maha FDA on Thursday mentioned that all the drug dealers (retailer/wholesaler) can sell allopathic medicines to registered homeopaths, who have completed the modern pharmacology course.
Further, the FDA clarified that there is no bar on the retail drug dealers to sell allopathic medicines prescribed by such homeopathic practitioners, TOI has reported.
“All retail and wholesale drug dealers can sell allopathic medicines to homeopathic registered doctors who completed the course, and retail drug dealers can sell drugs on prescription issued by these doctors,” stated the order issued by Maha FDA.
This directive comes almost a decade after the State Government redefined the “registered medical practitioners” under the Maharashtra Medical Council Act by including the homeopaths.
Referring to the recent directive, FDA Commissioner Rajesh Narvekar on Friday pointed out that there was confusion among the chemists about the allopathic prescriptions written by homeopaths. He added, “Our directive clearly states govt in 2016 changed definition of registered medical practitioner to include homeopaths who passed a certificate course in modern pharmacology recognised by state govt.”
Also Read: Homoeopathy doctors cannot practice Allopathy: High Court stay Government Order
Even though the homeopathic practitioners, led by the Maharashtra Homeopathic Council Administrator Dr. Bahubali Shah are happy with the new FDA directive allowing them to practice modern medicine, the modern medicine practitioners under the Indian Medical Associaion (IMA) are upset with this development.
As per the latest media report by the Times of India, IMA plans to seek legal recourse against this directive allowing “mixopathy“. Commenting on the matter, the President of IMA Maharashtra, Dr Santosh Kadam said, “We moved the courts when permission was given for them to practise, and the matter is still sub-judice. We will take up the FDA directive in court as well.”
Medical Dialogues had earlier reported that back in 2017, Maharashtra Medical Education and Drugs Department had passed a notification, allowing Homeopathy practitioners across the State to practice modern medicine. As per the special notification issued on 27th September 2017, doctors who obtained the Licentiate of Court of Examiners of Homeopathy (LCEH) degree from 1951-1982, could register with the Maharashtra Medical Council (MMC).
This directive was also strongly opposed by allopathic doctors in the State, who had questions how could homeopathy practitioners register with the Medical Council. The allopaths had also accused the government of promoting crosspathy.
later, when the IMA approached the Bombay High Court opposing the State Government notification, the HC bench had stayed the Maharashtra Medical Education and Drug Department’s notification that allowed homeopathic doctors to practice modern medicine.
Also Read: Homeopathy Practitioners can now practice Modern Medicine in Maharashtra
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New Delhi: President Droupadi Murmu will inaugurate the state-of-the-art Dr Sampat Kumar S Shivangi Cancer Hospital on December 30 in Belgagavi, Karnataka.
An Indian-American doctor has donated his family fortunes to build a cancer hospital in the rural parts of his home state of Karnataka. President Droupadi Murmu will inaugurate the hospital.
According to the PTI report, Dr Sampat Shivangi said in a statement, “Honourable President of India, Droupadi Muramu, has accepted the invitation and will inaugurate the newly built Dr Sampat Kumar S. Shivangi Cancer Hospital on December 30 in Belgagavi, Karnataka.”
“What an honour, the President of India will be inaugurating my dream facility, a most memorable and modern hospital in Belgaum, my home district, and at the medical college where I was an Assistant Professor,” he said.
As per a media report in the TOI, KLES Chairman Prabhakar Kore briefed the media about the event and the facilities of the new cancer hospital on Tuesday. The hospital, which cost Rs 300 crore, is spread over a 1,75,000 sqft area and is located behind the existing Dr Prabhakar Kore Hospital and Medical Research Centre.
Also Read:President Murmu confers Florence Nightingale Awards on 15 nurses for outstanding service
The hospital has a well-equipped daycare centre with trained staff for chemotherapy administration. It also provides nutritional counselling, physiotherapy, and other rehabilitation services to support the recovery of the patient. Additionally, it offers tailored plans for palliative care and pain management.
“Having lived in India for three decades, in not so privileged and progressive parts of the world, it always touched my heart and Atma why so, and why not we all have an equal playing field on the Earth,” the Mississippi-based doctor said.
“During my years in hospitals as a student, resident and staff, I was devastated. I had a great desire to do something that helps people, including the need to establish a cancer hospital in my native town where people have to travel hundreds of miles away for such treatment and possibly could not afford the travel, stay, or medical expenses,” he said.
Dr Shivangi said he went to his hometown in Karnataka to set up a Cancer hospital wherein he formed a committee and raised funds. “Made several trips to India and struggled to do something good, but returned home empty-handed,” he said.
His efforts and love to give back to his motherland came to fruition when he saw “an opportunity in my district to establish a world-class facility. I did not want to let it go. After several trips to India and collaborating with the local authorities, I am excited that Dr Sampat Kumar S Shivanagi Cancer Hospital has become a reality”, he said.
An eminent Indian-American community leader, Dr. Shivangi hopes that many more will follow him just as his dream has come true.
“I urge my fellow Indo-American physicians to join this movement and help change the world for the better. My humble request is that let us be the change, and bring this movement to make our world different tomorrow. I hope my prayers will be answered one day and all humanity lives in a better world,” he said.
Also Read:Karnataka to set up 5 new cancer hospitals
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Bengaluru: German biotechnology company BioNTech has reached two separate settlement agreements with the U.S. National Institutes of Health (NIH) and the University of Pennsylvania (Penn) regarding royalty payments related to its COVID-19 vaccine, according to recent filings.
BioNTech, which collaborated with U.S. pharmaceutical giant Pfizer for the vaccine, said on Friday that it would pay $791.5 million to the U.S. agency to resolve a default notice.
Separately, the company will pay $467 million to the University of Pennsylvania (Penn), which has agreed to dismiss a lawsuit brought against the vaccine maker accusing it of underpaying royalties.
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Bhopal: The Madhya Pradesh High Court has dismissed a plea alleging medical negligence against a doctor, emphasizing that prosecution of medical professionals requires expert opinion. The bench, led by Justice MS Bhatti, referenced the Supreme Court’s judgment in Jacob Mathew while hearing the petition of a man who sought the filing of an FIR against doctors at a private hospital.
The petitioner’s claim was that his son’s death, due to alleged negligence, amounted to culpable homicide.
The bench observed that the Supreme Court also referred to the “Bolam test” as the standard which determines that a medical professional
has performed his duty to provide care to the patient and that the procedure meant to treat the patient, has been duly followed by the medical
professionals.
The case goes back to 2022 when the son of the petitioner was admitted to Ashish Hospital,
Jabalpur on 27.1.2022 at about 11:15 AM for the purpose of surgery of a stone. On
27.1.2022, at about 8:00 PM, the surgery was conducted for about one hour and
after the surgery, the patient was shifted to a normal ward. On 29.1.2022 at
about 7:00 AM, the patient started feeling pain in his chest and fell down. The
petitioner claimed that the patient was not provided any emergency medical care
back, therefore, the patient died due to cardiac arrest.
Petitioner’s Submission:
The petitioner submitted that on
account of negligence while conducting the surgery, the son of the petitioner
died, and to substantiate the said contention, the counsel for the petitioner
stressed on the fact that the Blood Pressure reading of the patient was high and
in such circumstances, the surgery could not have been conducted. It was submitted that despite High Blood pressure, the patient’s surgery was performed, which amounted to medical
negligence and comes within the purview of an offence under Section 304-I of the
Indian Penal Code. It was also the petitioner’s grievance that the conduct
of the officials of the Ashish Hospital was suspicious as different IDs were
provided in the ECG report of the patient and no expert opinion was obtained.
Expert Committee Report:
The petitioner highlighted his grievance by approaching
various Authorities and the Chief Medical and Health Officer, then, constituted
a committee to conduct an enquiry. The enquiry was conducted by two qualified
Doctors and one of them was a Master of Surgery (General Surgery). The committee
of both the Doctors submitted a report and in the said report, it was clearly
mentioned that for different kinds of investigations in the Hospital, there were no
different counters and thus, there was a difference in ID numbers as well as
time.
The committee also
stated that the basic investigation of a patient is conducted before admission
and ultimately the persons accompanying the patient are instructed to make the
payment and obtain receipt thereof. In the meantime, the ECG investigation of the
patient was completed and thus, there was the possibility of a different time so far
as it related to conducting the ECG investigation as well as issuance of
receipt of ECG. The committee also dealt with the aspect of conducting surgery
where the Blood Pressure is 150/90 or 150/94
The committee reported that all the emergency equipment was
available at the Hospital. The Cardiac Catheterization Laboratory (CATH lab)
and all life-saving drugs were available in the Hospital and at the time of
cardiac arrest, the treatment was given by the doctor. The committee concluded
that after obtaining the medical fitness report of the patient, the surgery was not
conducted in a traditional manner but it was conducted through laparoscopy, in
which a hole is made to perform the surgery. It was also stated in the report that
after the surgery, the patient did not make any complaint and as such, the
surgery was successful. Thus, it is argued by the defendant from the report of the committee, that
the entire procedure was carried out in terms of the settled principles of
medical science.
The Court Order:
The bench observed that the complaints moved by the
petitioner were taken note of and the Chief Medical and Health Officer vide his
communication dated 8.6.2022 constituted a committee and the said committee,
which consisted of two Doctors including one Doctor being an expert in the field
of surgery, submitted its report and accordingly, in view of the said report the Authorities could have taken no action.
The counsel for the petitioner has placed heavy reliance on
the report of the Medical Board, Umaria but the same is of no assistance to him as
the said committee did not inspect the Hospital. However, if the report is perused from any angle nowhere suggests that the Doctors conducted the surgery in negligent and rash manner or the Doctors had not
followed a settled procedure of surgery in terms of medical science. “This
Court is of the considered view that as the onus was on the petitioner to
establish that there was rashness or negligence on the part of the Doctors
concerned and said onus having not been discharged in terms of the law laid
down in Jacob Mathew (supra), this Court is of the view that the petition filed
by the petitioner is devoid of the merits,” the court added.
The bench further mentioned:
It is reiterated that the
Police officials cannot be expected to act in a mechanical manner when they are
clueless about the ailment suffered by the patient, diagnosis by the medical
professional, and the treatment so provided to the patient. The said procedure
falls within the domain of the experts of the medical science and, therefore,
the FIR cannot be lodged in a routine manner in view of the observations made
by the Supreme Court in Jacob Mathews (supra).
To view the order, Click on the below link:
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