FDA Approves Calquence for Mantle Cell Lymphoma

Calquence (acalabrutinib) was granted an accelerated approval by the FDA to treat adult patients with mantle cell lymphoma (MCL) following at least one prior therapy.

"Mantle cell lymphoma is a particularly aggressive cancer", Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

Mantle cell lymphoma is a rare and fast-growing type of non-Hodgkin lymphoma and, according to the National Cancer Institute at the National Institutes of Health, represents 3 to 10 percent of all non-Hodgkin lymphoma cases in the U.S. Mantle cell lymphoma is a cancer of the lymph system, which is part of the body's immune system and is made up of lymph tissue, lymph nodes, the spleen, thymus, tonsils and bone marrow.

Calquence is a kinase inhibitor that works by blocking an enzyme needed by the cancer to multiply and spread. "For patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies". The approval was based on objective response rates (ORR) in a single-arm trial.

Under the accelerated approval program, full approval for acalabrutinib is contingent on findings from confirmatory trials. The investigators assessed how many patients experienced a complete or partial tumor shrinkage. Currently, the phase III ACE-LY-308 clinical trial is evaluating acalabrutinib in combination with bendamustine and rituximab (BR) versus placebo plus BR for patients with untreated MCL.

The most common adverse events (AEs) of any grade were anemia (46 percent), thrombocytopenia (44 percent), headache (39 percent), neutropenia (36 percent), diarrhea (31 percent), fatigue (28 percent), myalgia (21 percent) and bruising (21 percent), which is a known class effect for BTK inhibition. Serious side effects reported for acalabrutinib include hemorrhage, atrial fibrillation, and infections; there have also been reports of second primary malignancies.

For more from the FDA, including applications, designations and approvals, follow Rare Disease Report on Facebook and Twitter.

The FDA granted the accelerated approval of Calquence to AstraZeneca Pharmaceuticals LP.

Notícias recomendadas

  • Former Ravens WR Derrick Mason charged with felony domestic assault

    Former Ravens WR Derrick Mason charged with felony domestic assault

    The wide receiver officially announced his retirement at the Ravens' team facility in a news conference in June 2012. The 43-year-old Mason had fled before police arrived, and reported for booking after he heard of the warrants.
    Auburn RB Kamryn Pettway has fractured scapula

    Auburn RB Kamryn Pettway has fractured scapula

    It was his best game of the season since rushing for 128 yards and three scores in the team's Week 2 win over Mercer. "Kam Pettway suffered a fracture in his scapula", Malzahn said Tuesday. "We did not know that until last Friday".
    OGCN : Six mois plus tard, Cyprien est de retour

    OGCN : Six mois plus tard, Cyprien est de retour

    Seulement 16e de Ligue 1 après 11 journées, l'OGC Nice , corrigé par le PSG 3-0 vendredi dernier, fait grise mine. Arrivé à Nice en 2016 en provenance du RC Lens , le numéro 25 s'est vite imposé chez les Aiglons.
  • Financial Review of Microsoft Corporation (NASDAQ:MSFT)

    Bowling Mngmt Ltd Liability Corporation holds 1.27% of its portfolio in Microsoft Corporation (NASDAQ: MSFT ) for 124,824 shares. July 21 investment analysts at Citigroup left the stock rating at "Sell" but raised the price target from $60.00 to $74.00.

    Sonus Networks' (SONS) "Buy" Rating Reaffirmed at William Blair

    The company reported $0.12 earnings per share (EPS) for the quarter, topping analysts' consensus estimates of $0.09 by $0.03. BidaskClub lowered shares of Sonus Networks from a "hold" rating to a "sell" rating in a report on Tuesday, July 25th.
    Dartmouth College professors under investigation for alleged sexual misconduct

    Dartmouth College professors under investigation for alleged sexual misconduct

    MacDonald of New Hampshire said his office was part of a joint criminal investigation by five law enforcement agencies into allegations of "serious misconduct".
  • Bode Miller met fin à sa carrière à 40 ans

    Bode Miller met fin à sa carrière à 40 ans

    Je n'ai ni la motivation ni le désir de repartir encore une fois. "J'ai eu une longue carrière". Les choses ont suivi leur cours.
    Microsoft rep switches to Chrome mid-presentation because Edge kept crashing

    Microsoft rep switches to Chrome mid-presentation because Edge kept crashing

    A Microsoft engineer ditched Edge for Chrome during his Azure presentation as Microsoft Edge froze during the presentation . Do you think it would have been less embarrassing if he had installed Firefox or any other browser instead of Chrome?
    Kate visits Lawn Tennis Association and watches UK's top junior talent

    Kate visits Lawn Tennis Association and watches UK's top junior talent

    Kate, who is the LTA patron, proved to be a smash hit with tennis stars past, present and future during the visit. Duchess Kate practices a coordination drill with a young tennis player.
  • Data grows fourfold for Airtel but revenues continue to fall

    Data grows fourfold for Airtel but revenues continue to fall

    The company's consolidated debt has risen to ₹91,480 crore from ₹87,840 crore in the previous quarter. Investments were stepped up in the quarter to improve both data coverage and capacity, Airtel said.
    Zoo Mourns Loss Of Henry The Hippo

    Zoo Mourns Loss Of Henry The Hippo

    Numbers have declined by seven to 20 percent over the past 10 years and likely will continue to decline. "He was undoubtedly the most popular animal at Dickerson Park Zoo", said Zoo Director Mike Crocker.
    100-year-old woman dies after alleged rape in India

    100-year-old woman dies after alleged rape in India

    The victim was rushed to the hospital in critical condition and the doctors declared her dead after a medical examination. Meanwhile, villagers have sought the death sentence for Punia who has so far been sent to jail.

We are pleased to provide this opportunity to share information, experiences and observations about what's in the news.
Some of the comments may be reprinted elsewhere in the site or in the newspaper.
Thank you for taking the time to offer your thoughts.