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After selling Rubraca, Clovis Oncology unveils CRL for potential label expansion

Paul Schloesser Associate Editor Clovis Oncology is facing yet another setback with the FDA giving the battled company a complete response letter and rejecting a potential label expansion for its PARP inhibitor Rubraca. A new SEC filing Friday detailed how it received the CRL from the FDA on May 26, rejecting an sNDA for Rubraca as a first-line maintenance treatment for women with advanced ovarian cancer who are in complete or partial response to a first-line, platinum-based chemotherapy. FDA said that for the agency to reconsider the application, per the filing, Clovis would need to show results from an overall survival analysis that “do not demonstrate a potential OS detriment.” In the meantime, Clovis said that the FDA’s determination would impact the timing and achievability of milestone payments that Clovis is owed. The company sold rights to its PARP inhibitor to Swiss company pharma& Schweiz GmbH in an April deal ...
- Source: drugdu
- 209
- June 7, 2023
FDA OKs Injectafer for Iron Deficiency Anemia in Heart Failure

Megan Brooks The US Food and Drug Administration (FDA) has expanded the indication for ferric carboxymaltose injection (Injectafer, Daiichi Sankyo/American Regent) to include treatment of iron deficiency in adults with New York Heart Association (NYHA) class II/III heart failure (HF). “This new indication for Injectafer marks the first and only FDA approval of an intravenous iron replacement therapy for adult patients with heart failure,” Ravi Tayi, MD, MPH, chief medical officer at American Regent, said in a news release. Ferric carboxymaltose injection is also indicated for the treatment of iron deficiency anemia in adults and children as young as 1 year of age who have either intolerance or an unsatisfactory response to oral iron, and in adult patients who have nondialysis dependent chronic kidney disease. The new indication in HF was supported by data from the CONFIRM-HF randomized controlled trial that evaluated the efficacy and safety of ferric carboxymaltose injection ...
- Source: drugdu
- 137
- June 7, 2023
Study shows efficacy and safety of novel FolRα-targeting antibody drug conjugate in recurrent epithelial ovarian cancer

Updated dose expansion data of the phase I STRO-002-GM1 study have been presented today by Ana Oaknin, Principal Investigator of the Vall d’Hebron Institute of Oncology’s (VHIO) Gynecological Malignancies Group, on the ground at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), 2-6 June in Chicago, USA. This global study was designed to evaluate the efficacy and safety of the novel FolRα-targeting antibody drug conjugate (ADC) luveltamab tazevibulin (STRO-002 – luvelta) in patients with recurrent epithelial ovarian cancer with identified expression levels of folate receptor alpha (FolRα) higher than 25%. This ADC induces cytotoxic and immunologic cell death, and using site-specific conjugation technology and is designed to target a broad range of FolRα-expressing ovarian tumors. “Folate receptor alpha is a folate-binding protein overexpressed on ovarian and several other epithelial malignancies. Its overexpression in solid tumors promotes cancer cell proliferation and persists in metastatic or recurrent disease ...
- Source: drugdu
- 171
- June 6, 2023
Combination therapy successfully treats Pasteurella multocida-related invasive infections

Announcing a new article publication for Zoonoses journal. Pasteurella multocida, a Gram-negative, penicillin-sensitive coccobacillus that is frequently a member of the normal respiratory microbiota of different animals, remains a clinically important pathogen with the ability to cause severe disease. Few case reports have involved P. multocida infections without animal bites. Moreover, few reports have identified P. multocida as the causative agent of septic shock, which usually occurs in patients with cirrhosis and/or immunocompromised patients. To our knowledge, a human submandibular salivary gland abscess caused by P. multocida has not been reported. Pasteurella spp. are resistant to benzylpenicillin, and human isolates of beta-lactamase-producing resistant strains of P. multocida resistant have also been documented. The noteworthy findings of the current study were as follows: (i) the combination of ceftriaxone and ciprofloxacin successfully treated two patients infected with P. multocida; (ii) the first reported case of a septicemic patient with no history of ...
- Source: drugdu
- 128
- June 6, 2023
NICE recommends Bristol Myers’ heart drug Camzyos in UK

Paul Schloesser Associate Editor Bristol Myers Squibb’s heart drug Camzyos has been recommended by the National Institute for Health and Care Excellence as the medication inches closer to approval in the UK and Europe. In final draft guidance released Friday, NICE recommended mavacamten (branded as Camzyos) as an add-on to standard care for symptomatic obstructive hypertrophic cardiomyopathy. Obstructive HCM is a heart condition that occurs when part of the muscular wall in the heart becomes thicker, which can then reduce blood supply to the rest of the body. NICE recommended the drug for several reasons. While the standard care for the disease treats symptoms, the organization said Camzyos is the first to treat oHCM, as compared with beta blockers, certain calcium channel blockers or disopyramide. Some of those treatments have side effects and are not always effective, the organization said. “We’re therefore pleased to be able to recommend a treatment ...
- Source: drugdu
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- June 6, 2023
Dana-Farber research supports FDA approval of new therapy for metastatic breast cancer

Sacituzumab govitecan, a novel antibody drug-conjugate therapy was granted accelerated approval on February 3, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of metastatic HR+, HER2- breast cancer. The FDA action was based on the results of TROPICS-02, a study in which Dana-Farber Cancer Institute’s Sara Tolaney, MD, MPH, helped lead and which was presented at the European Society of Medical Oncology annual meeting in September 2022 as well as the American Society of Clinical Oncology meeting in June 2022. Researchers reported that the sacituzumab govitecan produced a statistically significant improvement in overall survival rates compared to chemotherapy. The overall survival rate for patients taking part in the global phase 3 study was 14.4 months for those who received sacituzumab govitecan and 11.2 for those given chemotherapy. The sacituzumab arm of the study also showed superior response rates as well as prolonged median progression free survival ...
- Source: drugdu
- 152
- June 6, 2023
Edelman

A new report by Edelman reveals an East-West divide in how people around the world view pharmaceutical businesses’ trustworthiness and their commitment “to do what is right.” Now in its second year, Edelman’s report found that people living in China, which is the world’s second largest and fastest growing pharma market, reported the highest level of trust in the industry (89%). China was closely followed by India, the world’s largest producer of generic medicines, where 86% of people trust the pharma industry. However, the numbers drop significantly in the West. In the U.K., 60% of people trust the pharma industry to do what is right, and the number dips to 55% in Germany and 52% in France. In the U.S., the world’s largest pharma market, 54% of people trust the pharma industry. The lowest ranking comes from Japan, home of Big Pharmas Eisai and Takeda, which registered a score of ...
- Source: drugdu
- 137
- June 6, 2023
After nabbing historic RSV shot approval, GSK looks to boost US vaccination rates

Rates of vaccination in the U.S. have dropped in recent years, with the COVID-19 pandemic hitting uptake. GSK, with a new vaccine to market, is looking to help turn this around.GSK is running a new “COiMMUNITY Initiative” that will add new funds, deeper data transparency and collaboration for all vaccine uptake across the country. On the money side, GSK said in a press release that it is “committing” up to $1 million in grant funding to support groups focused on adult immunization and health equity. On the data and collaboration side, GSK said it will continue to make adult vaccination claims data available through Vaccine Track platform, which publishes on a quarterly basis. The company also said it will “enhance the platform’s capabilities.” GSK is also looking to open the platform up to public and private stakeholders “to potentially integrate and host additional data and viewpoints on adult vaccination trends,” ...
- Source: drugdu
- 129
- June 6, 2023
Pfizer’s antibiotic combination shows promise in treating multi-drug resistant infections

Pfizer has announced positive phase 3 results supporting the safety and efficacy of its investigational antibiotic combination, aztreonam-avibactam (ATM-AVI), in treating serious infections caused by multi-drug resistant, gram-negative bacteria. Declared by the World Health Organization as one of the top ten threats to global health, antimicrobial resistance occurs when bacteria, viruses, fungi and parasites change and adapt to antibiotics over time. As a result, infections become harder to treat and the risk of disease spread, severe illness and death increases. Pfizer’s late-stage programme included a study which compared ATM-AVI and metronidazole with two older antibiotics – meropenem and colistin – for the treatment of complicated intra-abdominal infections, hospital-acquired pneumonia and ventilator-associated pneumonia. For patients with complicated intra-abdominal infections, the cure rate was 76.4% in the ATM-AVI plus metronidazole treatment group, versus 74% in the meropenem and colistin cohort. Additionally, for patients with hospital-acquired pneumonia and ventilator‐associated pneumonia, the cure rate ...
- Source: drugdu
- 122
- June 6, 2023
FDA allows temporary import of unapproved Chinese cancer drug to ease U.S. shortage

The U.S. Food and Drug Administration has authorized the temporary importation of an unapproved chemotherapy drug from China in effort to ease an acute shortage of cancer drugs in the United States, according to an update posted to the agency’s website Friday. Qilu Pharmaceutical, which makes and markets cisplatin injections in China, received FDA permission to export the drug to the U.S. market weeks ago, a document shows. A letter dated May 24 from Qilu’s deputy general manager notified health care professionals of the approval. Qilu is coordinating with a Toronto-based company, Apotex, to distribute 50-milligram cisplatin vials in the U.S. Health care providers can begin ordering the drug Tuesday through their wholesalers. Cisplatin is a generic drug that has been available for decades in the U.S. and is distributed by several approved manufacturers. Those manufacturers have been unable to keep up with demand. Qilu’s version of cisplatin is not ...
- Source: drugdu
- 134
- June 6, 2023

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